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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
Implant: 16mm x 18mm x 12mm Evans PEEK HA Wedge. 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. FDA UDI
Model / Reference
EVP-16-18-12 FDA UDI
Description
Implant: 16mm x 18mm x 12mm Evans PEEK HA Wedge. 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. FDA UDI

Identifiers

Primary DI / UDI-DI
00810005667708 FDA UDI
510(k) Number
K193414 FDA UDI
FDA Product Code
PLF 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
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

Dimensions & Sizes

Size
Length — 16 Millimeter FDA UDI
Width — 18 Millimeter FDA UDI
Depth — 12 Millimeter 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

K193414 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 d0782acf-efee-4ae6-bcce-734564c29f04 36 fields · synced May 30, 2026