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Axsos 703543

by Stryker Corp.

Ref 703543Model 08858251002990TS

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002990TS Basic UDI-DI 04546540693815UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04546540693815 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Fluted surgical drill bit, reusable
Device Name
Axsos Instruments - Opening Instrumentation - Class Iia - Non Sterile
Model / Ref / Catalog
703543, 08858251002990TS
Description
Cortical Opener , AO Fitting
Primary DI / UDI-DI
04546540693815
Basic UDI-DI
08858251002990TS
Direct Marketing DI
04546540693815
FDA Product Code
LXH
EMDN Code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN Term
Fluted surgical drill bit, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
888.4540
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Fluted surgical drill bit, reusable

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • CMR Substance
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No