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APEX Knee System KS-94516

by OMNIlife science, Inc.

Ref KS-94516Model Apex Knee Instruments

APEX Knee System KS-94516 is a device classified as Class IIa in the EU and Class I in the US made by OMNIlife science, Inc., registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI B-00841690197997) and listed in FDA GUDID since 27 Mar 2023 (UDI-DI 00841690197997), active as of 7 Nov 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00841690197997 Basic UDI-DI 00841690197997UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841690197997 UDI-DI Date27 Mar 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00841690197997 registered 21 Oct 2026 Active
  • FDA GUDID UDI-DI 00841690197997 listed 27 Mar 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841690197997
  2. Registered EUDAMED B-00841690197997

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  • Withdrawn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
AK3 PS-C Insert Trial Size 5 - 16mm EUDAMED
APEX Knee System GUDID
Generic name
Knee tibia prosthesis trial, reusable
Model / Ref / Catalog
KS-94516, Apex Knee Instruments
Primary DI / UDI-DI
00841690197997
Basic UDI-DI
B-00841690197997
FDA product code
HWT
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Knee tibia prosthesis trial, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4800
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Knee tibia prosthesis trial, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from OMNIlife science, Inc.

See all devices from OMNIlife science, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)