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Stealth AXiS 9736668

by Medtronic Navigation Inc.

Ref 9736668

Stealth AXiS 9736668 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 8 May 2026 (Basic UDI-DI 0763000B00033848J), cleared under FDA 510(k) K253381 on 12 Feb 2026 and listed in FDA GUDID since 14 Aug 2026 (UDI-DI 00763000995355), 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
United StatesGUDID listing GUDID Number00763000995355 UDI-DI Date14 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0763000B00033848J Basic UDI-DI 00763000995355UDI-DIDate8 May 2026RegisteredStatusActive
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 0763000B00033848J registered 8 May 2026 Active
  • FDA 510(k) K253381 decided 12 Feb 2026 Active
  • FDA GUDID UDI-DI 00763000995355 listed 14 Aug 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K253381
  2. Registered EUDAMED 0763000B00033848J
  3. Listed FDA GUDID 00763000995355

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  • Withdrawn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
Generic name
Multi-purpose stereotactic surgery system
Device name
Spine Stabilization Non-invasive
Model / reference
9736668
Primary DI / UDI-DI
00763000995355
Basic UDI-DI
0763000B00033848J
510(k) Number
FDA product code
OLO
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

Cleared under the same submission (K253381)

and 8 more cleared under K253381

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
  • Lot / batch number
Other properties (23, all answered No)