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6007-300-000

by Stryker Leibinger

Ref 6007-300-000Model 08858250000565S8

6007-300-000 is a device classified as Class I in the EU and Class II in the US made by Stryker Leibinger, registered in EUDAMED on 16 Oct 2026 (Basic UDI-DI 08858250000565S8) and listed in FDA GUDID since 12 Dec 2017 (UDI-DI 04546540403117), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858250000565S8 Basic UDI-DI 04546540403117UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04546540403117 UDI-DI Date12 Dec 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858250000565S8 registered 16 Oct 2026 Active
  • FDA GUDID UDI-DI 04546540403117 listed 12 Dec 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04546540403117
  2. Registered EUDAMED 08858250000565S8

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  • Withdrawn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

Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
Axis Guides
Model / Ref / Catalog
6007-300-000, 08858250000565S8
Primary DI / UDI-DI
04546540403117
Basic UDI-DI
08858250000565S8
Direct marketing DI
04546540403117
FDA product code
HAW, OLO
EMDN code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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 prosthesis implantation positioning instrument, reusable

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES.

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Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)