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Arthrex® AR-8545-95S

by Arthrex, Inc.

Ref AR-8545-95S

Arthrex® AR-8545-95S is a device classified as Class IIb in the EU and Class II in the US made by Arthrex, Inc., registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-00888867309517) and listed in FDA GUDID since 3 Dec 2019 (UDI-DI 00888867309517), 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-00888867309517 Basic UDI-DI 00888867309517UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888867309517 UDI-DI Date3 Dec 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00888867309517 registered 5 Nov 2026 Active
  • FDA GUDID UDI-DI 00888867309517 listed 3 Dec 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00888867309517
  2. Registered EUDAMED B-00888867309517

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  • Withdrawn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 bone screw (non-sliding)
Model / Ref / Catalog
AR-8545-95S
Primary DI / UDI-DI
00888867309517
Basic UDI-DI
B-00888867309517
FDA product code
HWC
EMDN code
P09120699 Bone fixation screws, tendon and ligament synthesis screws - other
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
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 bone screw (non-sliding)

Similar devices in this category

Other devices filed under BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER.

Other devices from Arthrex, Inc.

See all devices from Arthrex, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)