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9734563

by Medtronic Navigation Inc.

Ref 9734563

9734563 is a device classified as Class I in the EU and Class II in the US made by Medtronic Navigation Inc., registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI 0763000B00003417B) and listed in FDA GUDID since 23 May 2016 (UDI-DI 00763000255572), active as of 8 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 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00003417B Basic UDI-DI 00763000255572UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000255572 UDI-DI Date23 May 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00003417B registered 28 Oct 2026 Active
  • FDA GUDID UDI-DI 00763000255572 listed 23 May 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00763000255572
  2. Registered EUDAMED 0763000B00003417B

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  • Withdrawn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
Spinal implant trial
Device name
Interbody Trials
Model / reference
9734563
Primary DI / UDI-DI
00763000255572 EUDAMED
00643169085558 GUDID
Basic UDI-DI
0763000B00003417B
FDA product code
OLO
EMDN code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN term
Spinal implant trial
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
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
Primary DI / UDI-DIEUDAMED
00763000255572
GUDID
00643169085558
Device classEUDAMED
Class I
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00763000255572; FDA GUDID lists 00643169085558), so their flags are not compared. 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: Spinal implant trial

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Medtronic Navigation Inc.

See all devices from Medtronic Navigation Inc. →

Properties

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