RENAISSANCE— 510(k) K120812

Clearance details

Applicant

Mazor Robotics , Ltd.

Product code

Code HAW

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2012-03-16

Decision date

2012-07-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Kfar Saba, IL

• K253856 — Geniant Cranial (Navigated Neurosurgical Positioning Robot)2026-09-10
• K261932 — Leksell® Vantage Stereotactic System2026-08-05
• K253663 — Zeta Navigation System2026-05-01
• K253379 — Stealth AXiS Cranial clinical application2026-03-26
• K231897 — NeuroAlign software2025-10-21

• K251316 — Mazor X System / Mazor X Stealth Edition2025-09-11
• K230064 — Mazor X System (Mazor X Stealth Edition)2023-04-07
• K203005 — Mazor X2020-10-27
• K200935 — Mazor X2020-05-08
• K182077 — Mazor X System (Mazor X Stealth Edition)2018-11-02

Death

52

Injury

1,083

Malfunction

17,300

Total

18,435

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• 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.Class II·Terminated·Mazor Robotics Ltd·20141126

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120812.