Mazor Robotics Ltd
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 13
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1122-2026 | Class II | Mazor X robotic guidance system REF: TPL0059 | December 10, 2025 |
| Z-3156-2024 | Class II | Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument | July 17, 2024 |
| Z-0101-2024 | Class II | MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1 | September 5, 2023 |
| Z-0721-2020 | Class II | Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868 | July 2, 2019 |
| Z-0609-2019 | Class II | Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory | November 26, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K251316 | Mazor X System / Mazor X Stealth Edition | September 11, 2025 |
| K230064 | Mazor X System (Mazor X Stealth Edition) | April 7, 2023 |
| K203005 | Mazor X | October 27, 2020 |
| K200935 | Mazor X | May 8, 2020 |
| K182077 | Mazor X System (Mazor X Stealth Edition) | November 2, 2018 |
| K180307 | Mazor X | April 30, 2018 |
| K172522 | Mazor X | September 15, 2017 |
| K163221 | Mazor X | April 4, 2017 |
| K152041 | Renaissance X System | November 17, 2015 |
| K140167 | RENAISSANCE X SYSTEM | September 10, 2014 |
| K120812 | RENAISSANCE | July 12, 2012 |
| K113228 | RENAISSANCE SYSTEM | December 1, 2011 |
| K110911 | RENAISSANCE SYSTEM | April 28, 2011 |