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Ace™ 903003004

by Biomet Orthopedics, Inc.

Ref 903003004

Ace™ 903003004 is a device classified as Class IIa in the EU and Class I in the US made by Biomet Orthopedics, Inc., registered in EUDAMED on 24 Oct 2026 (Basic UDI-DI 889024-ZB002741-GC) and listed in FDA GUDID since 29 May 2023 (UDI-DI 00887868561511), active as of 7 Nov 2026.

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

CE MDR

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/MDR EUDAMED Number889024-ZB002741-GC Basic UDI-DI 00887868561511UDI-DIDate24 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868561511 UDI-DI Date29 May 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 889024-ZB002741-GC registered 24 Oct 2026 Active
  • FDA GUDID UDI-DI 00887868561511 listed 29 May 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00887868561511
  2. Registered EUDAMED 889024-ZB002741-GC

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  • Withdrawn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
Ace™
Generic name
Orthopaedic bone wire
Model / Ref / Catalog
903003004
Primary DI / UDI-DI
00887868561511
Basic UDI-DI
889024-ZB002741-GC
FDA product code
LXH
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Orthopaedic bone wire
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Netherlands
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: Orthopaedic bone wire

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)