APEX Knee System

FDA UDI

Class II (US FDA UDI)

by OMNIlife science, Inc.

Identity

Trade Name: APEX Knee System FDA UDI
Generic Name: Uncoated knee femur prosthesis, metallic FDA UDI
Device Name: High Performance PS Femoral Component, Size 6+ Left, Cemented FDA UDI
Model / Reference: KP-0065L-HP FDA UDI
Description: High Performance PS Femoral Component, Size 6+ Left, Cemented FDA UDI

Identifiers

Catalog Number: KP-0065L-HP FDA UDI
Primary DI / UDI-DI: 00841690131366 FDA UDI
FDA Product Code: JWH FDA UDI
GMDN Term: Uncoated knee femur prosthesis, metallic 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: Uncoated knee femur prosthesis, metallic

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

Similar devices

Also classified as Uncoated knee femur prosthesis, metallic.

SIGMA — DEPUY (IRELAND) · Class II
Natural-Knee® — Zimmer, Inc. · Class II
LEGION — Smith & Nephew, Inc. · Class II
LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG · Class II
Orthopedic Salvage System (OSS™) — Biomet Orthopedics, Inc. · Class II
GMK Sphere Revision System — Medacta International · Class II
ACS® — implantcast GmbH · Class II
Balance Knee Revision System — ORTHO DEVELOPMENT CORP. · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: OMNIlife science, Inc.

Sources (1)

FDA UDI 5b4ae56e-f3c6-4afd-88cb-94ecdf660768 35 fields · synced Jun 9, 2026