Mazor Robotics Ltd
Caesarea Haifa, IL
MAZOR ROBOTICS LTD. appears in FDA device records in Caesarea Haifa, IL. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Mazor Robotics Ltd between 2011 and 2025. The busiest year on record is 2011, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 2 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2017 | 2 |
| 2018 | 2 |
| 2020 | 2 |
| 2023 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251316 | Mazor X System / Mazor X Stealth Edition | OLO | Substantially Equivalent | |
| K230064 | Mazor X System (Mazor X Stealth Edition) | OLO | Substantially Equivalent | |
| K203005 | Mazor X | OLO | Substantially Equivalent | |
| K200935 | Mazor X | OLO | Substantially Equivalent | |
| K182077 | Mazor X System (Mazor X Stealth Edition) | OLO | Substantially Equivalent | |
| K180307 | Mazor X | OLO | Substantially Equivalent | |
| K172522 | Mazor X | OLO | Substantially Equivalent | |
| K163221 | Mazor X | OLO | Substantially Equivalent | |
| K152041 | Renaissance X System | OLO | Substantially Equivalent | |
| K140167 | RENAISSANCE X SYSTEM | OLO | Substantially Equivalent | |
| K120812 | RENAISSANCE | HAW | Substantially Equivalent | |
| K113228 | RENAISSANCE SYSTEM | HAW | Substantially Equivalent | |
| K110911 | RENAISSANCE SYSTEM | HAW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005075696 | 3005075696 | MAZOR ROBOTICS LTD. | 1 HaEshel Street (Building C), Caesarea Business Park, Caesarea Haifa 3079830 IL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1122-2026 | Mazor X robotic guidance system REF: TPL0059 | Software errors that can result in incorrect surgical instrument positioning during spinal surgery. | Class II | Open, Classified | |
| Z-3156-2024 | 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. | Class II | Open, Classified | |
| Z-0101-2024 | MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1 | Software update | Class II | Open, Classified | |
| Z-0721-2020 | 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 | Class II | Terminated | |
| Z-0609-2019 | 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 implants during general spinal and brain surgery. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects. | In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move. | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Mazor Robotics Ltd edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain