Skip to content

Autofix 903-0054

by Stryker GmbH

Ref 903-0054Model 08858251002813T3

Autofix 903-0054 is a Class I device made by Stryker GmbH, registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI 08858251002813T3) and listed in FDA GUDID since 21 Sep 2018 (UDI-DI 03700586903050), active as of 12 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002813T3 Basic UDI-DI 03700586903050UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700586903050 UDI-DI Date21 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002813T3 registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI 03700586903050 listed 21 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700586903050
  2. Registered EUDAMED 08858251002813T3

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Autofix
Generic name
Surgical instrument handle, non-torque-limiting
Device name
Autofix Instruments - Handles - Class I - Non Sterile
Model / Ref / Catalog
903-0054, 08858251002813T3
Primary DI / UDI-DI
03700586903050
Basic UDI-DI
08858251002813T3
FDA product code
HXX
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Surgical instrument handle, non-torque-limiting
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical instrument handle, non-torque-limiting

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES.

Other devices from Stryker GmbH

See all devices from Stryker GmbH →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)