510(k) K120812 ยท HAW Neurological Stereotaxic Instrument
RENAISSANCE
| Applicant | Mazor Robotics , Ltd., Kfar Saba, IL |
| Decision | Substantially Equivalent, Jul 12, 2012 |
| Received | Mar 16, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120812
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.