Trigon

Primary DI
00810135962230
Brand
Trigon
Company
NVISION BIOMEDICAL TECHNOLOGIES, INC.
Model
LMP-1414-0809
Device description
8mm Wedge 9° Transverse PEEK Small Single Joint Lesser Metatarsal 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 ArthrodesisThe 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.
Published
2025-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
HWCScrew, Fixation, Bone
PLFBone Wedge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
PLFBone WedgeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243231000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243231000Trigon PEEK HA WedgesNvision Biomedical Technologies2024-11-08PLF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810135962230PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810135962230008101359622308101359622300810135962230

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric osteotomy fusion cage, non-customizedA non-customized device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia) following osteotomy to help facilitate bone fusion and alignment; it is typically used with a plating fixation system and may be used in association with a bone substitute/graft. The device is typically designed as a small, wedge-shaped cylinder (or other geometric form) and is made of synthetic polymer [e.g., polyetheretherketone (PEEK)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle9degree
Width8Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
210-598-5938Denisealva@nvisionbiomed.com

Regulatory Flags#

DUNS number
047486041
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810005668088TrigonWD-1001C-7002026-04-24
00810005668095TrigonMTP-22-08-002026-04-24
00810005668101TrigonMTP-22-10-002026-04-24
00810005668118TrigonMTP-22-12-002026-04-24
00810005668125TrigonWD-1000T-MWIS2026-04-24
00810005668187TrigonMTP-18-08-002026-04-24
00810135963565TrigonMTP-18-10-002026-04-24
00810135963572TrigonMTP-18-12-002026-04-24
00810005668132TrigonMTP-22-08T-002026-04-23
00810005668149TrigonMTP-22-10T-002026-04-23
00810005668156TrigonMTP-22-12T-002026-04-23
00810135963589TrigonMTP-18-08T-002026-04-23
00810135963596TrigonMTP-18-10T-002026-04-23
00810135963602TrigonMTP-18-12T-002026-04-23
00810135960502Retropsoas ElectrodeELEC1000-042023-10-25
00810135960519Retropsoas ElectrodeELEC1000-062023-10-25
00810135960526Retropsoas ElectrodeELEC1000-082023-10-25
00810135960533Retropsoas ElectrodeELEC1000-102023-10-25
00810135960540Retropsoas ElectrodeELEC21002023-10-25
00810135960557Retropsoas ElectrodeELEC22402023-10-25

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