Company ยท IL
Mazor Robotics , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2025. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
5recalls (1 in 12 months)
5recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 2025 | K251316 | Mazor X System / Mazor X Stealth Edition Mazor Robotics , Ltd., IL | OLO |
| Apr 7, 2023 | K230064 | Mazor X System (Mazor X Stealth Edition) Mazor Robotics , Ltd., IL | OLO |
| Oct 27, 2020 | K203005 | Mazor X Mazor Robotics , Ltd., IL | OLO |
| May 8, 2020 | K200935 | Mazor X Mazor Robotics , Ltd., IL | OLO |
| Nov 2, 2018 | K182077 | Mazor X System (Mazor X Stealth Edition) Mazor Robotics , Ltd., IL | OLO |
| Apr 30, 2018 | K180307 | Mazor X Mazor Robotics , Ltd., IL | OLO |
| Sep 15, 2017 | K172522 | Mazor X Mazor Robotics , Ltd., IL | OLO |
| Apr 4, 2017 | K163221 | Mazor X Mazor Robotics , Ltd., IL | OLO |
| Nov 17, 2015 | K152041 | Renaissance X System Mazor Robotics , Ltd., IL | OLO |
| Sep 10, 2014 | K140167 | RENAISSANCE X SYSTEM Mazor Robotics , Ltd., IL | OLO |
| Jul 12, 2012 | K120812 | RENAISSANCE Mazor Robotics , Ltd., IL | HAW |
| Dec 1, 2011 | K113228 | RENAISSANCE SYSTEM Mazor Robotics , Ltd., IL | HAW |
| Apr 28, 2011 | K110911 | RENAISSANCE SYSTEM Mazor Robotics , Ltd., IL | HAW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2026 | Mazor Robotics Ltd Mazor X robotic guidance system
REF: TPL0059 Open, Classified |
OLO | K230064 |
| Sep 16, 2024 | Mazor Robotics Ltd Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument Open, Classified |
OLO | K230064 |
| Oct 12, 2023 | Mazor Robotics Ltd MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1 Open, Classified |
OLO | K203005 |
| Jul 2, 2019 | Mazor Robotics Ltd Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868 Terminated |
OLO | K182077 |
| Nov 26, 2014 | Mazor Robotics Ltd 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 instrume Terminated |
HAW | K120812 |