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APEX Knee System KR-53130

by OMNIlife science, Inc.

Ref KR-53130Model Apex Knee Instruments

APEX Knee System KR-53130 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 28 Oct 2026 (Basic UDI-DI B-00841690197119) and listed in FDA GUDID since 10 Jan 2023 (UDI-DI 00841690197119), 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-00841690197119 Basic UDI-DI 00841690197119UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841690197119 UDI-DI Date10 Jan 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00841690197119 registered 28 Oct 2026 Active
  • FDA GUDID UDI-DI 00841690197119 listed 10 Jan 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841690197119
  2. Registered EUDAMED B-00841690197119

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  • Withdrawn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
REVISION KNEE SPIRAL REAMER – HUDSON SHORT FLUTES, 13mm EUDAMED
APEX Knee System GUDID
Generic name
Bone-resection orthopaedic reamer, reusable
Model / Ref / Catalog
KR-53130, Apex Knee Instruments
Primary DI / UDI-DI
00841690197119
Basic UDI-DI
B-00841690197119
FDA product code
HTO
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Bone-resection orthopaedic reamer, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
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: Bone-resection orthopaedic reamer, 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
  • Premarket exempt
Other properties (22, all answered No)