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72205981

by Smith & Nephew, Inc.

Ref 72205981

72205981 is a device classified as Class IIb in the EU and Class II in the US made by Smith & Nephew, Inc., registered in EUDAMED on 18 Sep 2026 (Basic UDI-DI 0885556SN000663ML), cleared under FDA 510(k) K261968 on 9 Jul 2026 and listed in FDA GUDID since 5 Aug 2026 (UDI-DI 00885556926116), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K261968

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0885556SN000663ML Basic UDI-DI 00885556926116UDI-DIDate18 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00885556926116 UDI-DI Date5 Aug 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK261968 Date9 Jul 2026DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0885556SN000663ML registered 18 Sep 2026 Active
  • FDA 510(k) K261968 decided 9 Jul 2026 Active
  • FDA GUDID UDI-DI 00885556926116 listed 5 Aug 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K261968
  2. Listed FDA GUDID 00885556926116
  3. Registered EUDAMED 0885556SN000663ML

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Tendon/ligament bone anchor, non-bioabsorbable
Device name
ENDO Class IIb ENDO-TF-014 Q-Fix All-Suture Anchors
Model / Ref / Catalog
72205981
Primary DI / UDI-DI
00885556926116
Basic UDI-DI
0885556SN000663ML
510(k) Number
FDA product code
MBI
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
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

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

Cleared under the same submission (K261968)

Similar devices in this category

Other devices filed under ANCHORS, TENDON AND LIGAMENT SYNTHESIS.

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

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