510(k) K113228 ยท HAW Neurological Stereotaxic Instrument
RENAISSANCE SYSTEM
| Applicant | Mazor Robotics , Ltd., Kfar Saba, IL |
| Decision | Substantially Equivalent, Dec 1, 2011 |
| Received | Nov 1, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113228
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.