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Arthrex® AR-1324SF

by Arthrex, Inc.

Ref AR-1324SF

Arthrex® AR-1324SF is a device classified as Class IIb in the EU and Class II in the US made by Arthrex, Inc., registered in EUDAMED on 18 Sep 2026 (Basic UDI-DI 0888867Tak000000000000086) and listed in FDA GUDID since 15 Feb 2017 (UDI-DI 00888867010383), active as of 24 Oct 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0888867Tak000000000000086 Basic UDI-DI 00888867010383UDI-DIDate18 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888867010383 UDI-DI Date15 Feb 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0888867Tak000000000000086 registered 18 Sep 2026 Active
  • FDA GUDID UDI-DI 00888867010383 listed 15 Feb 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00888867010383
  2. Registered EUDAMED 0888867Tak000000000000086

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  • Withdrawn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
Arthrex®
Generic name
Tendon/ligament bone anchor, non-bioabsorbable
Device name
FastTak Anchor Devices
Model / Ref / Catalog
AR-1324SF
Primary DI / UDI-DI
00888867010383
Basic UDI-DI
0888867Tak000000000000086
FDA product code
HWC, MBI, JDR
EMDN code
P09120102 Anchors, tendon and ligament synthesis
GMDN term
Tendon/ligament bone anchor, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040, 888.3030
EU registration type
Standard device
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: Tendon/ligament bone anchor, non-bioabsorbable

Similar devices in this category

Other devices filed under ANCHORS, TENDON AND LIGAMENT SYNTHESIS.

Other devices from Arthrex, Inc.

See all devices from Arthrex, Inc. →

Properties

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