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Axsos 437404

by Stryker GmbH

Part of a family of 135 devices: see the family page

Ref 437404Model 08858251005293TJ

Axsos 437404 is a device classified as Class IIb in the EU and Class II in the US made by Stryker GmbH, registered in EUDAMED on 2 Sep 2026 (Basic UDI-DI 08858251005293TJ), cleared under FDA 510(k) K061012 on 19 May 2006 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 07613154395767), active as of 12 Nov 2026. 2 FDA recalls are linked to it.

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 ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K061012

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251005293TJ Basic UDI-DI 07613154395767UDI-DIDate2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613154395767 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK061012 Date19 May 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251005293TJ registered 2 Sep 2026 Active
  • FDA 510(k) K061012 decided 19 May 2006 Active
  • FDA GUDID UDI-DI 07613154395767 listed 24 Sep 2015 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1063-2009 FDA Unclassified (pre-2012) initiated 24 Nov 2008
    • Terminated Z-1062-2009 FDA Unclassified (pre-2012) initiated 24 Nov 2008

    Potential Breakage: Stryker Orthopaedics became aware that there is the potential for the tip of the AxSOS Screwdriver and the AxSOS Torque Limiter to break.

Timeline

5 dated events

  1. Cleared FDA 510(k) K061012
  2. Recall initiated FDA recalls Z-1063-2009
  3. Recall initiated FDA recalls Z-1062-2009
  4. Listed FDA GUDID 07613154395767
  5. Registered EUDAMED 08858251005293TJ

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  • Withdrawn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

Trade name
Axsos
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Device name
Axsos - Plate - Stainless Steel - Class Iib - Non Sterile
Model / Ref / Catalog
437404, 08858251005293TJ
Primary DI / UDI-DI
07613154395767
Basic UDI-DI
08858251005293TJ
510(k) Number
FDA product code
HRS
EMDN code
P09120599 Bone fixation plates - other
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 97.0 Millimeter

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 fixation plate, non-bioabsorbable

Cleared under the same submission (K061012)

and 8 more cleared under K061012

Similar devices in this category

Other devices filed under BONE FIXATION PLATES - OTHER.

Other devices from Stryker GmbH

See all devices from Stryker GmbH →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)