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Axsos 703591

by Stryker Corp.

Ref 703591Model 08858251002821T2

Axsos 703591 is a Class I device made by Stryker Corp., registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI 08858251002821T2) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04546540694133), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002821T2 Basic UDI-DI 04546540694133UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04546540694133 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002821T2 registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI 04546540694133 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04546540694133
  2. Registered EUDAMED 08858251002821T2

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  • Withdrawn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
Axsos
Generic name
Orthopaedic implantation sleeve, reusable
Device name
Axsos Instruments - Handles and Adaptors - Class I - Non Sterile
Model / Ref / Catalog
703591, 08858251002821T2
Primary DI / UDI-DI
04546540694133
Basic UDI-DI
08858251002821T2
FDA product code
LXH
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Orthopaedic implantation sleeve, reusable
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: Orthopaedic implantation sleeve, reusable

Similar devices in this category

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

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Sterilise before use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)