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OMNI Knee KC-35056

by OMNIlife science, Inc.

Ref KC-35056Model APEX Knee System

OMNI Knee KC-35056 is a device classified as Class III in the EU and Class II in the US made by OMNIlife science, Inc., registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI B-00841690101390) and listed in FDA GUDID since 27 Nov 2015 (UDI-DI 00841690101390), 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-00841690101390 Basic UDI-DI 00841690101390UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841690101390 UDI-DI Date27 Nov 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00841690101390 registered 25 Sep 2026 Active
  • FDA GUDID UDI-DI 00841690101390 listed 27 Nov 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841690101390
  2. Registered EUDAMED B-00841690101390

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  • Withdrawn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 Size 5 x 16mm Congruent Tibial Insert EUDAMED
OMNI Knee GUDID
Generic name
Tibial insert
Device name
Apex total knee congruent tibial inserts for use as a primary or revision total knee replacement
Model / Ref / Catalog
KC-35056, APEX Knee System
Primary DI / UDI-DI
00841690101390
Basic UDI-DI
B-00841690101390
FDA product code
JWH
EMDN code
P090903020202 Bicompartmental primary implant fixed bearing tibial inserts
GMDN term
Tibial insert
Device class
Class III EUDAMED
Class II GUDID
Regulation number
888.3560
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Ethylene Oxide

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Related devices

Category: Tibial insert

Other devices from OMNIlife science, Inc.

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Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)