510(k) K182417 ยท HAW Neurological Stereotaxic Instrument
ROSA ONE Brain Application
| Applicant | Medtech S.A, Montpellier, FR |
| Decision | Substantially Equivalent, Feb 7, 2019 |
| Received | Sep 5, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182417
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2021 | MEDTECH SAS ROSA One 3.1 Brain application
The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instr Open, Classified |
HAW | None listed |
| Jan 6, 2020 | MEDTECH SAS ROSA Brain 3.0 Application-Brain Terminated |
HAW | None listed |
| Jan 6, 2020 | MEDTECH SAS ROSA One 3.1 Brain Application Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.