510(k) K203005 ยท OLO Orthopedic Stereotaxic Instrument
Mazor X
| Applicant | Mazor Robotics , Ltd., Caesarea, IL |
| Decision | Substantially Equivalent, Oct 27, 2020 |
| Received | Oct 1, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K203005
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 12, 2023 | Mazor Robotics Ltd MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1 Open, Classified |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.