510(k) K151359 ยท HAW Neurological Stereotaxic Instrument
ROSA Brain
| Applicant | Medtech S.A, Montpellier, FR |
| Decision | Substantially Equivalent, Dec 18, 2015 |
| Received | May 20, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151359
| 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 |
| Mar 27, 2017 | Zimmer Biomet, Inc. MEDTECH ROSA Brain 3.0
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments ( Terminated |
HAW | None listed |
| Oct 11, 2016 | Zimmer Biomet, Inc. ROSA Brain, 3.0.0
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biop Terminated |
HAW | None listed |
| Jul 29, 2016 | Zimmer Biomet, Inc. ROSA BRAIN 3.0.0 Terminated |
HAW | None listed |
| Jul 20, 2016 | Zimmer Biomet, Inc. ROSA Brain 3.0.0
Usage:
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.