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9735522

by Medtronic Navigation Inc. 2 variants

Ref 9735522

9735522 is a device classified as Class IIa in the EU and Class II in the US made by Medtronic Navigation Inc., registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI 0763000B00007918E) and listed in FDA GUDID since 23 Jan 2020 (UDI-DI 00763000250515), 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 Number0763000B00007918E Basic UDI-DI 00763000250515UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000250515 UDI-DI Date23 Jan 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00007918E registered 23 Oct 2026 Active
  • FDA GUDID UDI-DI 00763000250515 listed 23 Jan 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00763000250515
  2. Registered EUDAMED 0763000B00007918E

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  • Withdrawn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
Multi-purpose stereotactic surgery system
Model / reference
9735522
Primary DI / UDI-DI
00763000250515
Basic UDI-DI
0763000B00007918E
FDA product code
OLO, MAX
EMDN code
Z12130480 Stereotactic orthopaedic surgery 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 00763000250515: 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 STEREOTACTIC ORTHOPAEDIC SURGERY 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)