APEX Knee System

FDA UDI

Class I (US FDA UDI)

by OMNIlife science, Inc.

Identity

Trade Name: APEX Knee System FDA UDI
Generic Name: Knee femur prosthesis trial, reusable FDA UDI
Device Name: PS Femur Trial Size 1 Right FDA UDI
Model / Reference: KT-0010R FDA UDI
Description: PS Femur Trial Size 1 Right FDA UDI

Identifiers

Catalog Number: KT-0010R FDA UDI
Primary DI / UDI-DI: 00841690116011 FDA UDI
FDA Product Code: HWT FDA UDI
GMDN Term: Knee femur prosthesis trial, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Knee femur prosthesis trial, reusable

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

Similar devices

Also classified as Knee femur prosthesis trial, reusable.

Lospa Modular Knee System — Corentec Co., Ltd · Class II
OSS™ — Biomet Orthopedics, Inc. · Class II
VANGUARD 360 INSTRUMENT — Biomet Orthopedics, Inc. · Class II
VANGUARD(TM) PS FEMORAL TRIAL — Biomet Orthopedics, Inc. · Class II
Natural-Knee® — Zimmer, Inc. · Class II
NexGen® — Zimmer, Inc. · Class II
LOSPA Knee System — Corentec Co., Ltd · Class II
Persona® — Zimmer, Inc. · 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 I	Pending data

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

Manufacturer

Manufacturer: OMNIlife science, Inc.

Sources (1)

FDA UDI c3ae0494-0775-49e8-8a16-ad901ab4dfcd 35 fields · synced Jun 9, 2026