510(k) K172444 ยท HAW Neurological Stereotaxic Instrument
ROSA BRAIN (v3.0.0.5)
| Applicant | Medtech S.A, Montpellier, FR |
| Decision | Substantially Equivalent, Mar 28, 2018 |
| Received | Aug 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172444
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Nov 1, 2019 | MEDTECH SAS Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped steril Terminated |
HAW | None listed |
| May 1, 2017 | Zimmer Biomet, Inc. ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device.
Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons. Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.