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Autopilot Tool Changer

by Medtronic Navigation Inc.

Ref 9736681

Autopilot Tool Changer (9736681) is a multi-purpose stereotactic surgery system (EU MDR Class I; FDA Class II; FDA product code OLO, Orthopedic stereotaxic instrument) made by Medtronic Navigation Inc., registered in EUDAMED on 8 May 2026 (Basic UDI-DI 0763000B00033858L), cleared under FDA 510(k) K253381 on 12 Feb 2026 and listed in FDA GUDID since 11 Apr 2026 (UDI-DI 00199150057078), 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 found

in data synced 8 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K253381

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 Number0763000B00033858L Basic UDI-DI 00199150057078UDI-DIDate8 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00199150057078 UDI-DI Date11 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK253381 Date12 Feb 2026DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00033858L registered 8 May 2026 Active
  • FDA 510(k) K253381 decided 12 Feb 2026 Active
  • FDA GUDID UDI-DI 00199150057078 listed 11 Apr 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K253381
  2. Listed FDA GUDID 00199150057078
  3. Registered EUDAMED 0763000B00033858L

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  • Withdrawn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

Trade name
Stealth AXiS
Axis Ap Robotic Tool Changer 9736681
Generic name
Multi-purpose stereotactic surgery system
Device name
Autopilot Tool Changer
Model / reference
9736681
Primary DI / UDI-DI
00199150057078, 00763000998493
Basic UDI-DI
0763000B00033858L
510(k) Number
FDA product code
OLO
EMDN code
Z12011401 Surgical navigation system
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 · 2 fields differ

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

Registry differences

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

  • Sterilise before use UDI-DI 00199150057078: EUDAMED states Yes, FDA GUDID states No.

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.

Manufacturer details

EUDAMED SRN
US-MF-000023263
Authorised representative
Medtronic B.V. NL-AR-000006050

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION SYSTEM.

Other devices from Medtronic Navigation Inc.

See all devices from Medtronic Navigation Inc. →

Properties

  • Sterilise before use YesEUDAMEDGUDIDNoGUDID
  • Serial number
Other properties (23, all answered No)