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Mazor X System TPL0059-10

by Mazor Robotics Ltd

Ref TPL0059

Mazor X System TPL0059-10 is a device classified as Class IIb in the EU and Class II in the US made by Mazor Robotics Ltd, registered in EUDAMED on 9 Jul 2026 (Basic UDI-DI 0763000B00026438C), cleared under FDA 510(k) K251316 on 11 Sep 2025 (1 earlier submission) and listed in FDA GUDID since 27 Apr 2025 (UDI-DI 07290115751895), active as of 24 Oct 2026. 2 FDA recalls are linked to it.

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

2 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K251316

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00026438C Basic UDI-DI 07290115751895UDI-DIDate9 Jul 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK251316 Date11 Sep 2025DecidedStatusActive
United StatesGUDID listing GUDID Number07290115751895 UDI-DI Date27 Apr 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00026438C registered 9 Jul 2026 Active
  • FDA 510(k) K251316 decided 11 Sep 2025 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07290115751895 listed 27 Apr 2025 Listed

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1122-2026 FDA Class II initiated 10 Dec 2025

    Software errors that can result in incorrect surgical instrument positioning during spinal surgery.

    • Ongoing Z-3156-2024 FDA Class II initiated 17 Jul 2024

    Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and the screw information presented on the screen.

Timeline

6 dated events

  1. Cleared FDA 510(k) K230064
  2. Recall initiated FDA recalls Z-3156-2024
  3. Listed FDA GUDID 07290115751895
  4. Cleared FDA 510(k) K251316
  5. Recall initiated FDA recalls Z-1122-2026
  6. Registered EUDAMED 0763000B00026438C

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
MAZOR X Stealth Edition EUDAMED
Mazor X System GUDID
Generic name
Multi-purpose stereotactic surgery system
Model / reference
TPL0059 EUDAMED
TPL0059-10 GUDID
Primary DI / UDI-DI
07290115751895
Basic UDI-DI
0763000B00026438C
510(k) Number
FDA product code
OLO, LLZ
EMDN code
Z12130401 Stereotactic orthopaedic surgery systems
GMDN term
Multi-purpose stereotactic surgery system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
882.4560, 892.2050
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
TPL0059
GUDID
TPL0059-10
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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 (K230064)

and 8 more cleared under K230064

Cleared under the same submission (K251316)

and 8 more cleared under K251316

Similar devices in this category

Other devices filed under STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS.

Other devices from Mazor Robotics Ltd

See all devices from Mazor Robotics Ltd →

Properties

  • Reusable
  • Serial number
Other properties (23, all answered No)