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Trigon

FDA UDI

Class II (US FDA UDI)

by Nvision Biomedical Technologies, Inc

Identity

Trade Name
Trigon FDA UDI
Generic Name
Polymeric osteotomy fusion cage, non-customized FDA UDI
Device Name
8mm Wedge 9° Transverse PEEK Large 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 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
LMP-1715-0809 FDA UDI
Description
8mm Wedge 9° Transverse PEEK Large 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 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
00810135962254 FDA UDI
510(k) Number
K243231 FDA UDI
FDA Product Code
PLF FDA UDI
HWC FDA UDI
HRS FDA UDI
GMDN Term
Polymeric osteotomy fusion cage, non-customized FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
888.3040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

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
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Width — 8.0 Millimeter FDA UDI
Angle — 9.0 degree FDA UDI

Category: Polymeric osteotomy fusion cage, non-customized

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

Similar devices

Also classified as Polymeric osteotomy fusion cage, non-customized.

Cleared under the same submission

K243231 also covers:

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 3f5ad3fd-3291-44de-b54f-4421752ff0e3 36 fields · synced Jun 8, 2026