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APEX Knee System KT-0010R

by OMNIlife science, Inc.

Ref KT-0010RModel Apex Knee Instruments

APEX Knee System KT-0010R 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-00841690116011) and listed in FDA GUDID since 10 Jan 2023 (UDI-DI 00841690116011), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00841690116011 Basic UDI-DI 00841690116011UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841690116011 UDI-DI Date10 Jan 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00841690116011 registered 21 Oct 2026 Active
  • FDA GUDID UDI-DI 00841690116011 listed 10 Jan 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841690116011
  2. Registered EUDAMED B-00841690116011

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  • Withdrawn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
PS Femur Trial Size 1 Right EUDAMED
APEX Knee System GUDID
Generic name
Knee femur prosthesis trial, reusable
Model / Ref / Catalog
KT-0010R, Apex Knee Instruments
Primary DI / UDI-DI
00841690116011
Basic UDI-DI
B-00841690116011
FDA product code
HWT
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Knee femur 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

Related devices

Category: Knee femur prosthesis trial, reusable

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Properties

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