APEX Knee System

FDA UDI

Class II (US FDA UDI)

by OMNIlife science, Inc.

Identity

Trade Name: APEX Knee System FDA UDI
Generic Name: Coated knee femur prosthesis FDA UDI
Device Name: CR Femoral Uncemented, Size 6+ Left FDA UDI
Model / Reference: KC-1465L FDA UDI
Description: CR Femoral Uncemented, Size 6+ Left FDA UDI

Identifiers

Catalog Number: KC-1465L FDA UDI
Primary DI / UDI-DI: 00841690129554 FDA UDI
FDA Product Code: JWH FDA UDI
MBH FDA UDI
GMDN Term: Coated knee femur prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
888.3565 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: Coated knee femur prosthesis

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

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PERSONA™ Trabecular Metal™ — Zimmer, Inc. · Class II
Persona® PPS® — Zimmer, Inc. · Class II
Genflex2 Total Knee System — GLOBUS MEDICAL, INC. · Class II
SIGMA — DEPUY (IRELAND) · 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 5511632c-b754-4da7-8560-d76e5a6cea19 35 fields · synced Jun 9, 2026