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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 tibia prosthesis trial, reusable FDA UDI
Device Name
AK3 PS-C Insert Trial Size 6, 11mm FDA UDI
Model / Reference
KS-94611 FDA UDI
Description
AK3 PS-C Insert Trial Size 6, 11mm FDA UDI

Identifiers

Catalog Number
KS-94611 FDA UDI
Primary DI / UDI-DI
00841690198031 FDA UDI
FDA Product Code
HWT FDA UDI
GMDN Term
Knee tibia 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Knee tibia 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 tibia prosthesis trial, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
OMNIlife science, Inc.

Sources (1)

  • FDA UDI f01647db-2389-433f-9727-518575f3bea0 35 fields · synced Jun 9, 2026