510(k) K151511 ยท OLO Orthopedic Stereotaxic Instrument
ROSA Spine
| Applicant | Medtech S.A, Montpellier, FR |
| Decision | Substantially Equivalent, Jan 4, 2016 |
| Received | Jun 4, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151511
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 1, 2017 | Zimmer Biomet, Inc. ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device.
Intended for the spatial positioning and orientation of instrument holders to be used by surgeons. Terminated |
OLO | None listed |
| Mar 27, 2017 | Zimmer Biomet, Inc. MEDTECH ROSA Spine 1.0.2
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 |
OLO | None listed |
| Oct 29, 2015 | Zimmer Biomet, Inc. Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons Terminated |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.