APEX Revision Knee

FDA UDI

Class II (US FDA UDI)

by OMNIlife science, Inc.

Identity

Trade Name: APEX Revision Knee FDA UDI
Generic Name: Uncoated knee femur prosthesis, metallic FDA UDI
Device Name: Revision Femur PS, cemented Size 1+ Left FDA UDI
Model / Reference: KP-0415L FDA UDI
Description: Revision Femur PS, cemented Size 1+ Left FDA UDI

Identifiers

Catalog Number: KP-0415L FDA UDI
Primary DI / UDI-DI: 00841690121206 FDA UDI
FDA Product Code: MBH FDA UDI
JWH FDA UDI
GMDN Term: Uncoated knee femur prosthesis, metallic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3565 FDA UDI
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 Revision Knee 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

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Manufacturer

Manufacturer: OMNIlife science, Inc.

Sources (1)

FDA UDI 094f8ad2-72c4-4552-96b0-2ed119011f13 35 fields · synced Jun 9, 2026