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72710445

by Smith & Nephew, Inc.

Part of a family of 137 devices: see the family page

Ref 72710445

72710445 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 9 Oct 2026 (Basic UDI-DI 0885556SN000580MF), cleared under FDA 510(k) K240061 on 20 Sep 2024 and listed in FDA GUDID since 9 May 2025 (UDI-DI 00885556895337), 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) K240061

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 Number0885556SN000580MF Basic UDI-DI 00885556895337UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00885556895337 UDI-DI Date9 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK240061 Date20 Sep 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0885556SN000580MF registered 9 Oct 2026 Active
  • FDA 510(k) K240061 decided 20 Sep 2024 Active
  • FDA GUDID UDI-DI 00885556895337 listed 9 May 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K240061
  2. Listed FDA GUDID 00885556895337
  3. Registered EUDAMED 0885556SN000580MF

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  • Withdrawn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
Orthopaedic bone screw (non-sliding)
Device name
Memphis Class IIB SNOI-TF-046 TAN FAN Screws
Model / Ref / Catalog
72710445
Primary DI / UDI-DI
00885556895337
Basic UDI-DI
0885556SN000580MF
510(k) Number
FDA product code
HWC
EMDN code
P09120604 Osteosynthesis nail-screw systems
GMDN term
Orthopaedic bone screw (non-sliding)
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 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)

Cleared under the same submission (K240061)

and 8 more cleared under K240061

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS NAIL-SCREW SYSTEMS.

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)