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Mazor X System TPL0059-09

by Mazor Robotics Ltd

Mazor X System TPL0059-09 is a Class II device made by Mazor Robotics Ltd, cleared under FDA 510(k) K203005 on 27 Oct 2020 and listed in FDA GUDID since 6 Jan 2022 (UDI-DI 07290115751376), active as of 22 Oct 2026. One FDA recall is 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

1 ongoing

This device is named in the recall

Documents

510(k) K203005

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290115751376 UDI-DI Date6 Jan 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK203005 Date27 Oct 2020IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K203005 decided 27 Oct 2020 Active
  • FDA GUDID UDI-DI 07290115751376 listed 6 Jan 2022 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0101-2024 FDA Class II initiated 5 Sep 2023

    Software update

Timeline

3 dated events

  1. Cleared FDA 510(k) K203005
  2. Listed FDA GUDID 07290115751376
  3. Recall initiated FDA recalls Z-0101-2024

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  • Withdrawn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 System
Generic name
Multi-purpose stereotactic surgery system
Model / reference
TPL0059-09
Primary DI / UDI-DI
07290115751376
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 (K203005)

and 8 more cleared under K203005

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

  • Convenience kit
  • Serial number
Other properties (13, all answered No)