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Trigon

FDA UDI

Class I (US FDA UDI)

by Nvision Biomedical Technologies, Inc

Identity

Trade Name
Trigon FDA UDI
Generic Name
General internal orthopaedic fixation system implantation kit FDA UDI
Device Name
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. FDA UDI
Model / Reference
WD-1000T-MKSL FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00810135962889 FDA UDI
FDA Product Code
MDM FDA UDI
GMDN Term
General internal orthopaedic fixation system implantation kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: General internal orthopaedic fixation system implantation kit

Trigon by Nvision Biomedical Technologies, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General internal orthopaedic fixation system implantation kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nvision Biomedical Technologies, Inc

Sources (1)

  • FDA UDI d9a55dd9-d3b2-45d5-b3fd-de0dc420d572 34 fields · synced Jun 1, 2026