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Arthrex® AR-8954ML-L

by Arthrex, Inc.

Ref AR-8954ML-L

Arthrex® AR-8954ML-L is a device classified as Class IIb in the EU and Class II in the US made by Arthrex, Inc., registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-00888867055292) and listed in FDA GUDID since 15 Feb 2017 (UDI-DI 00888867055292), 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-00888867055292 Basic UDI-DI 00888867055292UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888867055292 UDI-DI Date15 Feb 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00888867055292 registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 00888867055292 listed 15 Feb 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00888867055292
  2. Registered EUDAMED B-00888867055292

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  • Withdrawn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
Arthrex®
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Model / Ref / Catalog
AR-8954ML-L
Primary DI / UDI-DI
00888867055292
Basic UDI-DI
B-00888867055292
FDA product code
HRS, HWC
EMDN code
P09120503 Osteosynthesis screw-plate systems
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030, 888.3040
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
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS SCREW-PLATE SYSTEMS.

Other devices from Arthrex, Inc.

See all devices from Arthrex, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)