510(k) K230064 ยท OLO Orthopedic Stereotaxic Instrument
Mazor X System (Mazor X Stealth Edition)
| Applicant | Mazor Robotics , Ltd., Caesarea Business Park, IL |
| Decision | Substantially Equivalent, Apr 7, 2023 |
| Received | Jan 9, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230064
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2026 | Mazor Robotics Ltd Mazor X robotic guidance system
REF: TPL0059 Open, Classified |
OLO | None listed |
| Sep 16, 2024 | Mazor Robotics Ltd Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument Open, Classified |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.