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Medtronic 9735500

by Medtronic Navigation Inc. 2 variants

Ref 9735500

Medtronic 9735500 is a multi-purpose stereotactic surgery system (EU MDR Class IIa; FDA Class II) made by Medtronic Navigation Inc., registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI 0763000B00007898T) and listed in FDA GUDID since 17 Jan 2025 (UDI-DI 00763000971427), 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 Number0763000B00007898T Basic UDI-DI 00763000971427UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000971427 UDI-DI Date17 Jan 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00007898T registered 23 Oct 2026 Active
  • FDA GUDID UDI-DI 00763000971427 listed 17 Jan 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00763000971427
  2. Registered EUDAMED 0763000B00007898T

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  • Withdrawn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
Medtronic
Generic name
Multi-purpose stereotactic surgery system
Device name
Ref Set 9735500 Spine Refrencing
Model / reference
9735500
Primary DI / UDI-DI
00763000971427
Basic UDI-DI
0763000B00007898T
FDA product code
OLO, MAX
EMDN code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN term
Multi-purpose stereotactic surgery system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4560, 888.3080
System or procedure pack
Procedure pack
EU registration type
System or procedure pack
Medical purpose
Този процедурен пакет е предназначен за навигирана гръбначна хирургия
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00763000971427: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIa 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: Multi-purpose stereotactic surgery system

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 NoEUDAMEDYesGUDID
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)