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APEX CR Knee

FDA UDI

Class II (US FDA UDI)

by OMNIlife science, Inc.

Identity

Trade Name
APEX CR Knee FDA UDI
Generic Name
Uncoated knee tibia prosthesis, metallic FDA UDI
Device Name
Retaining Bolt Congruent or Ultra, Primary Tibia Baseplate FDA UDI
Model / Reference
KC-53000 FDA UDI
Description
Retaining Bolt Congruent or Ultra, Primary Tibia Baseplate FDA UDI

Identifiers

Catalog Number
KC-53000 FDA UDI
Primary DI / UDI-DI
00841690102014 FDA UDI
FDA Product Code
JWH FDA UDI
GMDN Term
Uncoated knee tibia prosthesis, metallic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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
Sterilization Method
Ethylene Oxide FDA UDI

Category: Uncoated knee tibia prosthesis, metallic

APEX CR Knee 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

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Manufacturer

Manufacturer
OMNIlife science, Inc.

Sources (1)

  • FDA UDI 1498cf39-cd9a-4769-9bb9-c0344438108c 35 fields · synced Jun 9, 2026