NVISION BIOMEDICAL TECHNOLOGIES, INC

Matched from indexed company URL: Nvision Biomedical Technologies

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30113013133011301313NVISION BIOMEDICAL TECHNOLOGIES, INC1Y2026-01-0112449 Silicon Dr San Antonio TX US 78249

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
00810005667227Trigon - Instrument: Lapidus wedge screw sleeve assembly. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.+1 210-598-5648anikajosephsmith@nvisionbiomed.com
00810005668163Vertex - Instrument-Vertex Staple Placement Pin: The Vertex Nitinol Staple System consists of a series of nickel titanium alloy staple implants and the instruments necessary for the treatment of pathologies of the foot and ankle.210-545-3713anikajosephsmith@nvisionbiomed.com
00810135963374Impact - PEEK Nail Cutter 3.0mm The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.2105985938denisealva@nvisionbiomed.com
00810135963404Impact - Kwire Depth Gauge The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.2105985938denisealva@nvisionbiomed.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1783362009141418K250646Impact PEEK Union Nail SystemHTY2025-06-11
1783361922713739K243231Trigon PEEK HA WedgesPLF2024-11-08
1783361687571204K242896Caliber Intramedullary Fixation SystemHWC2025-02-05
1783361612753645K2402503D Printed PEEK Interbody SystemMAX2024-09-17
1783361678059981K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemPLF2024-01-26
1783361858342312K231453SnapHammer Hammertoe Correction SystemHWC2024-02-16
1783361577725291K223226Trigon™ HA Stand-Alone Wedge Fixation SystemPLF2022-12-01
1783361467646533K222015Integral Titanium Cervical InterbodyODP2023-07-05
1783361649362954K220197Trigon HA Wedge Fixation SystemPLF2022-02-23
1783361176923325K213421Vector® Hammertoe Correction SystemHWC2021-11-19
1783361830845334K211650The Radian MIS Bunion SystemHRS2021-11-24
1783361659004310K210424Quantum Anterior Cervical PlateKWQ2021-10-22
1783361442513658K202657Javelin Tailor's Bunion Fixation SystemHRS2020-12-14
1783361289695785K201850Vector Hammertoe Correction SystemHWC2020-08-04
1783361180951484K200914Healix Compression Screw SystemHWC2020-05-05
1783361827564091K200428Multi-Drive Interference Screw SystemMBI2020-11-10
1783361741246327K193645nva, nvp, and nvtMAX2020-01-13
1783361974594616K193414Trigon HA Stand-Alone Wedge Fixation SystemPLF2020-02-25
1783361559406247K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemPLF2019-12-23
1783362028435702K190380nvcODP2019-03-21
1783361525864231K183055Vector Hammertoe Correction SystemHWC2019-02-19
1783361188753095K182949Healix™ Compression Screw SystemHWC2018-12-04
1783361268147912K182943VERTEX Nitinol Staple SystemJDR2019-04-04
1783361004295049K180458FOCUS Pedicle Screw SystemNKB2018-04-17
1783361691842512K173091Boundary Anterior Lumbar Buttress PlateKWQ2017-12-06
1783361234010720K170074nvcODP2017-01-24
1783361743004811K162426nva, nvp, and nvtMAX2016-09-29
1783361051650944K161524Tangis Anterior Cervical PlateKWQ2016-09-02
1783361926510214K142594nva, nvp, nvtMAX2014-11-28
1783361584091262K142328nvcODP2014-12-23
1783361114991854
1783361142481306
1783361176835741
1783361215086719
1783361256140705
1783361286329936
1783361306095919
1783361319402742
1783361532001481
1783361560314429
1783361584893023
1783361665689343
1783361745628825
1783361932111467
1783361992589691
1783362019553385
1783362035958244
1783362063174435

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
HWC72025-02-05
PLF62024-11-08
MAX42024-09-17
ODP42023-07-05
KWQ32021-10-22
HRS22021-11-24
HTY12025-06-11
MBI12020-11-10
JDR12019-04-04
NKB12018-04-17

PMN

Nvc

2019-03-21

Nvision Biomedical Technologies, Inc.

Nvc

2017-01-24

Nvision Biomedical Technologies, LLC

Nvc

2014-12-23

NVISION BIOMEDICAL TECHNOLOGIES, LLC

GUDID

Impact - Kwire 1.4mmx127mm single trocar The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-09-24

Impact - Mallet The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-09-24

Impact - PEEK Nail Slap Hammer The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-09-24

Impact - Kwire Depth Gauge The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-09-24

Impact - PEEK Nail Cutter 3.0mm The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-09-24

Impact - PEEK Nail Cutter 4.0mm The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-09-24

Impact - PEEK Union Nail 4.0 Countersink Shaft The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-09-24

Impact - PEEK Union Nail 3.0 countersink shaft The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-09-24

Impact - PEEK Nail 3.0 Drill Guide The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-09-23

Impact - PEEK Nail 4.0 Drill Guide The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-09-23

Impact - Impact PEEK Union Nail 3.0 Inserter Shaft/PEEK Union Nail3.0mm Inserter Sleeve The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-09-22

Impact - Impact PEEK Union Nail 4.0 Inserter Shaft/PEEK Union Nail 4.0mm Inserter Sleeve The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-09-22

Impact - PEEK Nail Cannulated 3.0mm drill. The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-09-22

Impact - PEEK Nail Cannulated 4.0mm drill. The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-09-22

Impact - PEEK Nail 2.0mm extraction drill. The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace). The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-09-22

Trigon - 6mmx30mm radius PEEK small standard midfoot wedge The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton (opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis • Calcaneal Z Lengthening Osteotomies • MTP Lengthening Arthrodesis • Lesser Metatarsal-Cuneiform Lengthening Arthrodesis • Navicular-Cuneiform Arthrodesis • Talonavicular Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-07-25

Trigon - Trigon Midfoot Case Assembly The Trigon HA Stand-Alone Wedge Fixation System is a family of PEEK Optima HA Enhanced (HA PEEK) wedges with tantalum markers used for angular correction of small bones of the foot. The wedges incorporate an inserter-receiving hole and/or two screw-receiving holes and an area to contain grafting material. The wedges are designed in rectangular, kidney, circular, oval, and teardrop shaped footprints in a range of sizes and in multiple thicknesses.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-07-25

Trigon - Midfoot Wedge Wide Screw Targeting Guide Assembly The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton (opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis • Calcaneal Z Lengthening Osteotomies • MTP Lengthening Arthrodesis • Lesser Metatarsal-Cuneiform Lengthening Arthrodesis • Navicular-Cuneiform Arthrodesis • Talonavicular Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-07-25

Trigon - Instrument: 6mm Trial 70mm radius PEEK large wide midfoot The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton (opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis • Calcaneal Z Lengthening Osteotomies • MTP Lengthening Arthrodesis • Lesser Metatarsal-Cuneiform Lengthening Arthrodesis • Navicular-Cuneiform Arthrodesis • Talonavicular Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-07-25

Trigon - Instrument: 6mm Trial 70mm radius PEEK Small wide midfoot The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton (opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis • Calcaneal Z Lengthening Osteotomies • MTP Lengthening Arthrodesis • Lesser Metatarsal-Cuneiform Lengthening Arthrodesis • Navicular-Cuneiform Arthrodesis • Talonavicular Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-07-25

Trigon - Instrument: 6mm Trial 30mm radius PEEK Large standard midfoot The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton (opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis • Calcaneal Z Lengthening Osteotomies • MTP Lengthening Arthrodesis • Lesser Metatarsal-Cuneiform Lengthening Arthrodesis • Navicular-Cuneiform Arthrodesis • Talonavicular Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-07-25

Trigon - Instrument: 6mm Trial 30mm radius PEEK Small standard midfoot The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton (opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis • Calcaneal Z Lengthening Osteotomies • MTP Lengthening Arthrodesis • Lesser Metatarsal-Cuneiform Lengthening Arthrodesis • Navicular-Cuneiform Arthrodesis • Talonavicular Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-07-25

Trigon - Midfoot Wedge Staple Drill Guide The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton (opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis • Calcaneal Z Lengthening Osteotomies • MTP Lengthening Arthrodesis • Lesser Metatarsal-Cuneiform Lengthening Arthrodesis • Navicular-Cuneiform Arthrodesis • Talonavicular Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-07-25

Trigon - Midfoot Wedge Kwire Sleeve The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton (opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis • Calcaneal Z Lengthening Osteotomies • MTP Lengthening Arthrodesis • Lesser Metatarsal-Cuneiform Lengthening Arthrodesis • Navicular-Cuneiform Arthrodesis • Talonavicular Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-07-25

Trigon - Midfoot Wedge Standard Screw Targeting Guide Assembly The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton (opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis • Calcaneal Z Lengthening Osteotomies • MTP Lengthening Arthrodesis • Lesser Metatarsal-Cuneiform Lengthening Arthrodesis • Navicular-Cuneiform Arthrodesis • Talonavicular Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-07-25

Trigon - 6mmx70mm radius PEEK large wide midfoot wedge The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton (opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis • Calcaneal Z Lengthening Osteotomies • MTP Lengthening Arthrodesis • Lesser Metatarsal-Cuneiform Lengthening Arthrodesis • Navicular-Cuneiform Arthrodesis • Talonavicular Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-07-25

Trigon - 6mmx70mm radius PEEK small wide midfoot wedge The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton (opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis • Calcaneal Z Lengthening Osteotomies • MTP Lengthening Arthrodesis • Lesser Metatarsal-Cuneiform Lengthening Arthrodesis • Navicular-Cuneiform Arthrodesis • Talonavicular Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-07-25

Trigon - 6mmx30mm radius PEEK large standard midfoot wedge The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton (opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis • Calcaneal Z Lengthening Osteotomies • MTP Lengthening Arthrodesis • Lesser Metatarsal-Cuneiform Lengthening Arthrodesis • Navicular-Cuneiform Arthrodesis • Talonavicular Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2025-07-25

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