FDA.reportPublic FDA data

NVISION BIOMEDICAL TECHNOLOGIES, INC

Matched from indexed company URL: Nvision Biomedical Technologies, LLC

FDA Registration(s)#

Registration, FEI, Name table
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 GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00810005668088Trigon - The Caddy is designed to securely store and organize MTP wedges during surgical procedures and processing It supports efficient workflow by enabling easy identification access and handling of wedges. It is made from durable medical grade materials suitable for repeated cleaning and sterilization+1 210-598-5648anikajosephsmith@nvisionbiomed.com
00810005668095Trigon - Implant: 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. This system is indicated for the lengthening arthrodesis of the metatarsophalangeal joint. 18mm diameter and 22mm diameter footprints are provided, in heights of 8mm, 10mm, and 12mm to accommodate for a wide patient population, allowing for precise and reliable application.+1 210-598-5648anikajosephsmith@nvisionbiomed.com
00810005668101Trigon - Implants: This system is indicated for the lengthening arthrodesis of the metatarsophalangeal joint. 18mm diameter and 22mm diameter footprints are provided, in heights of 8mm, 10mm, and 12mm to accommodate for a wide patient population, allowing for precise and reliable application. 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.The Trigon MTP Wedge System can be combined with ancillary fixation via the staples provided.+1 210-598-5648anikajosephsmith@nvisionbiomed.com
00810005668118Trigon - Implants: This system is indicated for the lengthening arthrodesis of the metatarsophalangeal joint. 18mm diameter and 22mm diameter footprints are provided, in heights of 8mm, 10mm, and 12mm to accommodate for a wide patient population, allowing for precise and reliable application. 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.The Trigon MTP Wedge System can be combined with ancillary fixation via the staples provided.+1 210-598-5648anikajosephsmith@nvisionbiomed.com
00810005668125Trigon - 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
00810005668187Trigon - Implant: 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. This system is indicated for the lengthening arthrodesis of the metatarsophalangeal joint. 18mm diameter and 22mm diameter footprints are provided, in heights of 8mm, 10mm, and 12mm to accommodate for a wide patient population, allowing for precise and reliable application.+1 210-598-5648anikajosephsmith@nvisionbiomed.com
00810135963565Trigon - Implant: 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. This system is indicated for the lengthening arthrodesis of the metatarsophalangeal joint. 18mm diameter and 22mm diameter footprints are provided, in heights of 8mm, 10mm, and 12mm to accommodate for a wide patient population, allowing for precise and reliable application.+1 210-598-5648anikajosephsmith@nvisionbiomed.com
00810135963572Trigon - Implant: 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. This system is indicated for the lengthening arthrodesis of the metatarsophalangeal joint. 18mm diameter and 22mm diameter footprints are provided, in heights of 8mm, 10mm, and 12mm to accommodate for a wide patient population, allowing for precise and reliable application.+1 210-598-5648anikajosephsmith@nvisionbiomed.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
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 code, Registration listing records, Latest decision table
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#

Trigon - Implants: This system is indicated for the lengthening arthrodesis of the metatarsophalangeal joint. 18mm diameter and 22mm diameter footprints are provided, in heights of 8mm, 10mm, and 12mm to accommodate for a wide patient population, allowing for precise and reliable application. 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.The Trigon MTP Wedge System can be combined with ancillary fixation via the staples provided.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2026-04-24

Trigon - Implants: This system is indicated for the lengthening arthrodesis of the metatarsophalangeal joint. 18mm diameter and 22mm diameter footprints are provided, in heights of 8mm, 10mm, and 12mm to accommodate for a wide patient population, allowing for precise and reliable application. 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.The Trigon MTP Wedge System can be combined with ancillary fixation via the staples provided.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2026-04-24

Boundary - Instrument, Lumbar Buttress Plate Ratchet Sport Grip AO Handle. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2018-11-12

Boundary - Buttress Plate 25mm long, 0 degree. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2018-02-28

Boundary - Buttress Plate 25mm long, 8 degree. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2018-02-28

Boundary - Buttress Plate 20mm long, 0 degree. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2018-02-28

Boundary - Buttress Plate 20mm long, 8 degree. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2018-02-28

Boundary - Buttress Plate 15mm long, 0 degree. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2018-02-28

Boundary - Buttress Plate 15mm long, 8 degree. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2018-02-28

tangis - Anterior Cervical Plating System, 4.25mm dia. 12mm long variable screw. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2017-02-28

tangis - Anterior Cervical Plating System, 4 level implant. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. Itis to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2017-02-28

tangis - Anterior Cervical Plating System, 4 level implant. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. Itis to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis

NVISION BIOMEDICAL TECHNOLOGIES, INC.

2017-02-28

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