Data / Medical devices / Israel / Mazor Robotics Ltd.
Mazor Robotics Ltd.: FDA-registered device maker in Caesarea Haifa, Israel, 7 510(k) clearances
Mazor Robotics Ltd. is registered with the FDA (registration 3005075696) in Caesarea Haifa, Israel. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 11, 2025. 5 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005075696
- Address
- 1 HaEshel Street (Building C), Caesarea Business Park, Caesarea Haifa, Israel, 3079830
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 26, 2019
- Registered through
- 2027
- Brand names listed
- Mazor X, Mazor X Stealth Edition, Mazor X System, Mazor X System (Mazor X Stealth Edition)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 11, 2025 | K251316 | Mazor X System / Mazor X Stealth Edition | OLO | Substantially Equivalent | Mazor Robotics , Ltd. | accessdata.fda.gov |
| April 7, 2023 | K230064 | Mazor X System (Mazor X Stealth Edition) | OLO | Substantially Equivalent | Mazor Robotics , Ltd. | accessdata.fda.gov |
| October 27, 2020 | K203005 | Mazor X | OLO | Substantially Equivalent | Mazor Robotics , Ltd. | accessdata.fda.gov |
| May 8, 2020 | K200935 | Mazor X | OLO | Substantially Equivalent | Mazor Robotics , Ltd. | accessdata.fda.gov |
| July 12, 2012 | K120812 | RENAISSANCE | HAW | Substantially Equivalent | Mazor Robotics , Ltd. | accessdata.fda.gov |
| December 1, 2011 | K113228 | RENAISSANCE SYSTEM | HAW | Substantially Equivalent | Mazor Robotics , Ltd. | accessdata.fda.gov |
| April 28, 2011 | K110911 | RENAISSANCE SYSTEM | HAW | Substantially Equivalent | Mazor Robotics , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 10, 2025 | 98199 | Class II | Ongoing | Mazor X robotic guidance system REF: TPL0059 | Software errors that can result in incorrect surgical instrument positioning during spinal surgery. | accessdata.fda.gov |
| July 17, 2024 | 95189 | Class II | Ongoing | Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument | 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. | accessdata.fda.gov |
| September 5, 2023 | 93070 | Class II | Ongoing | MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1 | Software update | accessdata.fda.gov |
| July 2, 2019 | 84328 | Class II | Terminated | Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868 | The firm has become aware that the Snapshot Trackers were not manufactured in accordance with specifications and could potentially lead to navigational inaccuracies, which may result in patient injury, e.g. nerve damage or neurological deficit/dysfunction | accessdata.fda.gov |
| November 26, 2014 | 81521 | Class II | Terminated | Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implant | In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Orthopedic Stereotaxic Instrument
- All makers of Neurological Stereotaxic Instrument
Updated January 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.