← Back to catalogue

APEX Knee System

FDA UDI

Class II (US FDA UDI)

by OMNIlife science, Inc.

Identity

Trade Name
APEX Knee System FDA UDI
Generic Name
Uncoated knee tibia prosthesis, metallic FDA UDI
Device Name
Primary Tibial Baseplate Cemented, Pegged, size 4 Right FDA UDI
Model / Reference
KC-2804R FDA UDI
Description
Primary Tibial Baseplate Cemented, Pegged, size 4 Right FDA UDI

Identifiers

Catalog Number
KC-2804R FDA UDI
Primary DI / UDI-DI
00841690132868 FDA UDI
FDA Product Code
MBH FDA UDI
JWH FDA UDI
GMDN Term
Uncoated knee tibia 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Uncoated knee tibia prosthesis, metallic

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

Similar devices

Also classified as Uncoated knee tibia prosthesis, metallic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
OMNIlife science, Inc.

Sources (1)

  • FDA UDI 70375fed-be1a-4fec-87e1-aa13a925b112 35 fields · synced Jun 9, 2026