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APEX Knee System KR-50001

by OMNIlife science, Inc.

Ref KR-50001Model Apex Knee Instruments

APEX Knee System KR-50001 is a Class I device made by OMNIlife science, Inc., registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI B-00841690117858) and listed in FDA GUDID since 10 Jan 2023 (UDI-DI 00841690117858), active as of 24 Oct 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00841690117858 Basic UDI-DI 00841690117858UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841690117858 UDI-DI Date10 Jan 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00841690117858 registered 21 Oct 2026 Active
  • FDA GUDID UDI-DI 00841690117858 listed 10 Jan 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841690117858
  2. Registered EUDAMED B-00841690117858

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  • Withdrawn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
Mod Tibia Conical Reamer Guide EUDAMED
APEX Knee System GUDID
Generic name
Surgical drill guide, reusable
Model / Ref / Catalog
KR-50001, Apex Knee Instruments
Primary DI / UDI-DI
00841690117858
Basic UDI-DI
B-00841690117858
FDA product code
FZX
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Surgical drill guide, reusable
Device class
Class I
Regulation number
878.4800
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

Related devices

Category: Surgical drill guide, reusable

Other devices from OMNIlife science, Inc.

See all devices from OMNIlife science, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Premarket exempt
Other properties (22, all answered No)