Mazor Robotics , Ltd.

Medical device manufacturer in Caesarea, Isra.

13510(k) clearances
0PMA approvals
5recalls

Device types

510(k) clearances

510(k)DeviceDecision
K251316Mazor X System / Mazor X Stealth EditionOLO · Traditional 09/11/2025SE
K230064Mazor X System (Mazor X Stealth Edition)OLO · Traditional 04/07/2023SE
K203005Mazor XOLO · Special 10/27/2020SE
K200935Mazor XOLO · Special 05/08/2020SE
K182077Mazor X System (Mazor X Stealth Edition)OLO · Traditional 11/02/2018SE
K180307Mazor XOLO · Special 04/30/2018SE
K172522Mazor XOLO · Special 09/15/2017SE
K163221Mazor XOLO · Traditional 04/04/2017SE
K152041Renaissance X SystemOLO · Special 11/17/2015SE
K140167Renaissance X SystemOLO · Traditional 09/10/2014SE
K120812RenaissanceHAW · Traditional 07/12/2012SE
K113228Renaissance SystemHAW · Special 12/01/2011SE
K110911Renaissance SystemHAW · Special 04/28/2011SE

Recalls

RecallProductInitiated
Z-1122-2026 Class IIMazor X robotic guidance system REF: TPL0059Software errors that can result in incorrect surgical instrument positioning during spinal surgery. 12/10/2025Open, Classified
Z-3156-2024 Class IIMazor X. Model Number REF TPL0059; stereotaxic orthopedic instrumentSoftware anomalies which can result in two separate issues: A lagging screen display during a navigated… 07/17/2024Open, Classified
Z-0101-2024 Class IIMAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1Software update 09/05/2023Open, Classified
Z-0721-2020 Class IISnapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868The firm has become aware that the Snapshot Trackers were not manufactured in accordance with specifications… 07/02/2019Terminated
Z-0609-2019 Class IICarousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit…In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the… 11/26/2014Terminated