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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 Ultra Insert Trial Size 5, 13mm FDA UDI
Model / Reference
KS-92513 FDA UDI
Description
AK3 Ultra Insert Trial Size 5, 13mm FDA UDI

Identifiers

Catalog Number
KS-92513 FDA UDI
Primary DI / UDI-DI
00841690198765 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

No

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

No

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 8167c366-3c4c-49cb-a2d0-07673702050f 35 fields · synced Jun 9, 2026