APEX Knee System

FDA UDI

Class II (US FDA UDI)

by OMNIlife science, Inc.

Identity

Trade Name: APEX Knee System FDA UDI
Generic Name: Knee arthroplasty wedge FDA UDI
Device Name: High Performance Revision Tibia Augment, Size 1 x 4mm FDA UDI
Model / Reference: KC-54010-HP FDA UDI
Description: High Performance Revision Tibia Augment, Size 1 x 4mm FDA UDI

Identifiers

Catalog Number: KC-54010-HP FDA UDI
Primary DI / UDI-DI: 00841690131021 FDA UDI
FDA Product Code: JWH FDA UDI
GMDN Term: Knee arthroplasty wedge FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Knee arthroplasty wedge

APEX Knee System by OMNIlife science, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Knee arthroplasty wedge.

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ADVANCE® — MicroPort Orthopedics Inc. · Class II
3DMetal Diaphyseal Femoral Cones — Medacta International · Class II
LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG · Class II
LEGION — Smith & Nephew, Inc. · Class II
ADVANTIM® — MicroPort Orthopedics Inc. · Class II
LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KG · Class II
Unity Total Knee System — CORIN LTD · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: OMNIlife science, Inc.

Sources (1)

FDA UDI 67b07bda-0122-4d45-91f7-4164a9217413 35 fields · synced Jun 9, 2026