Mazor X System / Mazor X Stealth Edition is an AI-enabled medical device from Mazor Robotics Ltd., listed by FDA (510(k), K251316) with a decision date of 2025-09-11. Review panel: Neurology.
| FDA submission number | K251316 |
|---|---|
| Pathway | 510(k) |
| Company | Mazor Robotics Ltd. |
| Review panel (specialty) | Neurology |
| FDA decision date | 2025-09-11 |
| Decision | Substantially Equivalent |
| Product code | OLO |
| Classification | Orthopedic Stereotaxic Instrument |
| Device class | 2 |
| Regulation number | 882.4560 |
| Review time (calendar days) | 135 |
| Applicant country | IL |
Official FDA database record · FDA AI-enabled device list
All Neurology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.