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Mazor X Navigation Camera TPL0063-70

by Mazor Robotics Ltd

Mazor X Navigation Camera TPL0063-70 is a Class II device made by Mazor Robotics Ltd, cleared under FDA 510(k) K251316 on 11 Sep 2025 (1 earlier submission) and listed in FDA GUDID since 29 Jan 2025 (UDI-DI 07290115752199), active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK251316 Date11 Sep 2025DecidedStatusActive
United StatesGUDID listing Number07290115752199 UDI-DI Date29 Jan 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251316 decided 11 Sep 2025 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07290115752199 listed 29 Jan 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

5 dated events

  1. Cleared FDA 510(k) K230064
  2. Recall initiated FDA recalls Z-3156-2024
  3. Listed FDA GUDID 07290115752199
  4. Cleared FDA 510(k) K251316
  5. Recall initiated FDA recalls Z-1122-2026

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mazor X Navigation Camera
Generic name
Multi-purpose stereotactic surgery system
Model / reference
TPL0063-70
Primary DI / UDI-DI
07290115752199
510(k) Number
FDA product code
OLO, LLZ
GMDN term
Multi-purpose stereotactic surgery system
Device class
Class II
Regulation number
882.4560, 892.2050
GUDID distribution status
In Commercial Distribution

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 Multi-purpose stereotactic surgery system.

Other devices from Mazor Robotics Ltd

See all devices from Mazor Robotics Ltd →

Properties

  • Serial number
Other properties (14, all answered No)