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Oxford® Partial Knee System 512211150

by Biomet Uk Ltd

Ref 512211150

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024-ZB003980-HN Basic UDI-DI 00889024683815UDI-DIDate4 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024683815 UDI-DI Date9 Apr 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Oxford® Partial Knee System
Generic Name
Surgical implant template, reusable
Device Name
Oxford Anatomic Tibia X-Ray Templates
Model / Ref / Catalog
512211150
Primary DI / UDI-DI
00889024683815
Basic UDI-DI
889024-ZB003980-HN
FDA Product Code
HWT
EMDN Code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN Term
Surgical implant template, reusable
Device Class
Class I
Regulation Number
888.4800
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

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Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No