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Axsos 370003

by Stryker GmbH

Ref 370003Model 08858251005281TB

Axsos 370003 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 08858251005281TB), cleared under FDA 510(k) K100475 on 30 Apr 2010 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 07613154089468), active as of 12 Nov 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 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K100475

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 Number08858251005281TB Basic UDI-DI 07613154089468UDI-DIDate2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613154089468 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK100475 Date30 Apr 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08858251005281TB registered 2 Sep 2026 Active
  • FDA 510(k) K100475 decided 30 Apr 2010 Active
  • FDA GUDID UDI-DI 07613154089468 listed 24 Sep 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K100475
  2. Listed FDA GUDID 07613154089468
  3. Registered EUDAMED 08858251005281TB

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  • Withdrawn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 inorganic implant inserter/extractor, reusable
Device name
Axsos - Insert - Stainless Steel - Class Iib - Non Sterile
Model / Ref / Catalog
370003, 08858251005281TB
Primary DI / UDI-DI
07613154089468
Basic UDI-DI
08858251005281TB
510(k) Number
FDA product code
HRS, HWC
EMDN code
P09120699 Bone fixation screws, tendon and ligament synthesis screws - other
GMDN term
Orthopaedic inorganic implant inserter/extractor, reusable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030, 888.3040
EU registration type
Standard device
EU market of registration
Netherlands
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 inorganic implant inserter/extractor, reusable

Similar devices in this category

Other devices filed under BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER.

Other devices from Stryker GmbH

See all devices from Stryker GmbH →

Properties

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