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Omni Stable AF 155-12902

by Extremity Medical, LLC

Ref 155-12902

Omni Stable AF 155-12902 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 1 Sep 2026 (Basic UDI-DI B-00842078130094), cleared under FDA 510(k) K212297 on 20 Aug 2021 and listed in FDA GUDID since 9 Jun 2023 (UDI-DI 00842078130094), 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-00842078130094 Basic UDI-DI 00842078130094UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842078130094 UDI-DI Date9 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-00842078130094 registered 1 Sep 2026 Active
  • FDA 510(k) K212297 decided 20 Aug 2021 Active
  • FDA GUDID UDI-DI 00842078130094 listed 9 Jun 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K212297
  2. Listed FDA GUDID 00842078130094
  3. Registered EUDAMED B-00842078130094

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  • Withdrawn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 fixation plate, non-bioabsorbable, non-sterile
Model / reference
155-12902
Primary DI / UDI-DI
00842078130094
Basic UDI-DI
B-00842078130094
510(k) Number
FDA product code
HRS
EMDN code
P09120503 Osteosynthesis screw-plate systems
GMDN term
Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
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 fixation plate, 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 OSTEOSYNTHESIS SCREW-PLATE SYSTEMS.

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)