Mazor Robotics , Ltd.
Mazor Robotics , Ltd. holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2025, with 5 FDA device recalls on record.
Top product codes for Mazor Robotics , Ltd.
FDA recalls by Mazor Robotics , Ltd.
- Z-1122-2026 — Mazor X robotic guidance system REF: TPL0059
- Z-3156-2024 — Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
- Z-0101-2024 — MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1
- Z-0721-2020 — Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Mazor Robotics , Ltd.
- K251316 — Mazor X System / Mazor X Stealth Edition
- K230064 — Mazor X System (Mazor X Stealth Edition)
- K203005 — Mazor X
- K200935 — Mazor X
- K182077 — Mazor X System (Mazor X Stealth Edition)
- K180307 — Mazor X
- K172522 — Mazor X
- K163221 — Mazor X
- K152041 — Renaissance X System
- K140167 — RENAISSANCE X SYSTEM
- K120812 — RENAISSANCE
- K113228 — RENAISSANCE SYSTEM
- K110911 — RENAISSANCE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.