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Trauma Fixation Systems 14-441047

by Biomet Orthopedics, Inc.

Ref 14-441047

Trauma Fixation Systems 14-441047 is a Class I device made by Biomet Orthopedics, Inc., registered in EUDAMED on 24 Oct 2026 (Basic UDI-DI B-00887868470622) and listed in FDA GUDID since 7 Jan 2022 (UDI-DI 00887868470622), 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-00887868470622 Basic UDI-DI 00887868470622UDI-DIDate24 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868470622 UDI-DI Date7 Jan 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00887868470622 registered 24 Oct 2026 Active
  • FDA GUDID UDI-DI 00887868470622 listed 7 Jan 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00887868470622
  2. Registered EUDAMED B-00887868470622

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  • Withdrawn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
Trauma Fixation Systems
Generic name
Orthopaedic inorganic implant inserter/extractor, reusable
Device name
Biomet Impactor Cap
Model / Ref / Catalog
14-441047
Primary DI / UDI-DI
00887868470622
Basic UDI-DI
B-00887868470622
FDA product code
LXH
EMDN code
L091106 Instruments for the preparation of tissue implants in orthopaedic and traumatological surgery, reusable
GMDN term
Orthopaedic inorganic implant inserter/extractor, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic inorganic implant inserter/extractor, reusable

Similar devices in this category

Other devices filed under INSTRUMENTS FOR THE PREPARATION OF TISSUE IMPLANTS IN ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY, REUSABLE.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

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