ROSA Brain
FDA 510(k) clearance K151359 · decided 2015-12-18
Clearance details
- K-number
- K151359
- Device name
- ROSA Brain
- Applicant
- Medtech S.A
- Decision
- Substantially Equivalent
- Date received
- 2015-05-20
- Decision date
- 2015-12-18
- Days to decision
- 212 days
- Clearance type
- Traditional
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Montpellier, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and recall (Z-0172-2020) | MEDTECH SAS | 2019-11-01 |
| MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning and orientation recall (Z-1754-2017) | Zimmer Biomet, Inc. | 2017-03-27 |