Skip to content

Arthrex® AR-5050K-2

by Arthrex, Inc.

Ref AR-5050K-2

Arthrex® AR-5050K-2 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-10888867217710) and listed in FDA GUDID since 3 Dec 2021 (UDI-DI 10888867217710), 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-10888867217710 Basic UDI-DI 10888867217710UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10888867217710 UDI-DI Date3 Dec 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10888867217710 registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 10888867217710 listed 3 Dec 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10888867217710
  2. Registered EUDAMED B-10888867217710

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  • Withdrawn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 pin, non-bioabsorbable
Model / Ref / Catalog
AR-5050K-2
Primary DI / UDI-DI
10888867217710
Basic UDI-DI
B-10888867217710
FDA product code
HTY
EMDN code
P09120503 Osteosynthesis screw-plate systems
GMDN term
Orthopaedic bone pin, non-bioabsorbable
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
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 bone pin, 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)