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APEX Revision Knee KC-52554

by OMNIlife science, Inc.

Ref KC-52554Model APEX Knee System

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00841690124450 Basic UDI-DI 00841690124450UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841690124450 UDI-DI Date27 Nov 2015ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
APEX Knee System 15mm x 150mm x 4mm Revision Offset Stem EUDAMED
APEX Revision Knee GUDID
Generic Name
Knee femur stem prosthesis
Device Name
Apex total knee revision offset stem for use as a primary or revision total knee replacement
Model / Ref / Catalog
KC-52554, APEX Knee System
Primary DI / UDI-DI
00841690124450
Basic UDI-DI
B-00841690124450
FDA Product Code
JWH, MBH
EMDN Code
P0909800601 Knee prostheses femoral stems
GMDN Term
Knee femur stem prosthesis
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
888.3560, 888.3565
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Knee femur stem prosthesis

Other devices from OMNIlife science, Inc.

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No