510(k) K101791 ยท HAW Neurological Stereotaxic Instrument
ROSA SURGICAL DEVICE
| Applicant | Medtech S.A.S, Montpellier, FR |
| Decision | Substantially Equivalent, Sep 23, 2010 |
| Received | Jun 28, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101791
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2018 | MEDTECH SAS ROSA(TM) Robotized Stereotactic Assistant, Version 2.5
ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positionin Terminated |
HAW | None listed |
| May 27, 2016 | Zimmer Biomet, Inc. ROSA Brain 3.0
Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicat Terminated |
HAW | None listed |
| Apr 8, 2016 | Zimmer Biomet, Inc. ROSA Surgical Device 2.5.8 Terminated |
HAW | None listed |
| Jan 20, 2016 | Zimmer Biomet, Inc. Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Ed Terminated |
HAW | None listed |
| Nov 6, 2014 | Zimmer Biomet, Inc. ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments. Terminated |
HAW | None listed |
| Sep 5, 2014 | Zimmer Biomet, Inc. ROSA Surgical Device 2.5.8
ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instru Terminated |
HAW | None listed |
| Jun 4, 2014 | Zimmer Biomet, Inc. ROSA Surgical Device 2.5.8
It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative pl Terminated |
HAW | None listed |
| Feb 14, 2014 | Zimmer Biomet, Inc. ROSA Surgical Device 2.5.8.
It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide Terminated |
HAW | None listed |
| Dec 18, 2013 | Zimmer Biomet, Inc. ROSA Surgical Device 2.5.8
ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instr Terminated |
HAW | None listed |
| Feb 10, 2013 | Zimmer Biomet, Inc. ROSA Surgical Device 2.5.8 Terminated |
HAW | None listed |
| Feb 5, 2013 | Zimmer Biomet, Inc. ROSA Surgical Device 2.5.8
ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an inst Terminated |
HAW | None listed |
| Apr 19, 2012 | Zimmer Biomet, Inc. ROSA Surgical Device 2.5.8
ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instr Terminated |
HAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.