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9734924

by Medtronic Navigation Inc.

Ref 9734924

9734924 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 27 Oct 2026 (Basic UDI-DI 0763000B00003447H), cleared under FDA 510(k) K182104 on 2 Nov 2018 and listed in FDA GUDID since 11 Aug 2022 (UDI-DI 00763000423094), active as of 8 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K182104

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00003447H Basic UDI-DI 00763000423094UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000423094 UDI-DI Date11 Aug 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK182104 Date2 Nov 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00003447H registered 27 Oct 2026 Active
  • FDA 510(k) K182104 decided 2 Nov 2018 Active
  • FDA GUDID UDI-DI 00763000423094 listed 11 Aug 2022 Listed

Recalls

1 recall · FDA

    • Terminated Z-1693-2020 FDA Class II initiated 28 Aug 2019 on shared 510(k) K182104

    Product was incorrectly assembled which could affect navigation accuracy of the device.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K182104
  2. Recall initiated FDA recalls Z-1693-2020
  3. Listed FDA GUDID 00763000423094
  4. Registered EUDAMED 0763000B00003447H

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Multi-purpose stereotactic surgery system
Device name
Robotic Reference Frame
Model / reference
9734924
Primary DI / UDI-DI
00763000423094
Basic UDI-DI
0763000B00003447H
510(k) Number
FDA product code
HAW
EMDN code
Z12011480 Surgical navigation instruments - hardware accessories
GMDN term
Multi-purpose stereotactic surgery system
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 · 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: Multi-purpose stereotactic surgery system

Cleared under the same submission (K182104)

and 1 more cleared under K182104

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