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Omni Stable AF 144-35054

by Extremity Medical, LLC

Ref 144-35054

Omni Stable AF 144-35054 is a device classified as Class IIb in the EU and Class II in the US made by Extremity Medical, LLC, registered in EUDAMED on 17 Sep 2026 (Basic UDI-DI B-00842078127711), cleared under FDA 510(k) K212297 on 20 Aug 2021 and listed in FDA GUDID since 12 Jun 2023 (UDI-DI 00842078127711), active as of 25 Oct 2026.

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

CE MDD 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) K212297

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/MDD EUDAMED NumberB-00842078127711 Basic UDI-DI 00842078127711UDI-DIDate17 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842078127711 UDI-DI Date12 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK212297 Date20 Aug 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00842078127711 registered 17 Sep 2026 Active
  • FDA 510(k) K212297 decided 20 Aug 2021 Active
  • FDA GUDID UDI-DI 00842078127711 listed 12 Jun 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K212297
  2. Listed FDA GUDID 00842078127711
  3. Registered EUDAMED B-00842078127711

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Omni Stable AF
Generic name
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Model / reference
144-35054
Primary DI / UDI-DI
00842078127711
Basic UDI-DI
B-00842078127711
510(k) Number
FDA product code
HWC
EMDN code
P09120601 Cortical screws
GMDN term
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

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-bioabsorbable, non-sterile

Cleared under the same submission (K212297)

and 8 more cleared under K212297

Similar devices in this category

Other devices filed under CORTICAL SCREWS.

Other devices from Extremity Medical, LLC

See all devices from Extremity Medical, LLC →

Properties

  • Sterilise before use
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
Other properties (18, all answered No)