Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K192173
ROSA ONE Spine application · Medtech S.A · decided 2019-10-29 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| RED Q-CONNECT NAV REF | 174059-01 | MEDTECH | OLO | 03760244033505 |
| YELLOW Q-CONNECT NAV REF | 174060-01 | MEDTECH | OLO | 03760244033512 |
| ROSTAR CLAMP | 174132-00 | MEDTECH | OLO | 03760244032942 |
| Navigation probe | 151026-00 | MEDTECH | OLO | 03760244034038 |
| ROSTAR CLAMP | 174132-01 | MEDTECH | OLO | 03760244033581 |
| NOTCHED LONG ADPTOR ø5.95mm | 174147-00 | MEDTECH | OLO | 03760244032980 |
| YELLOW Q-CONNECT NAV REF | 174060-00 | MEDTECH | OLO | 03760244030252 |
| 3D X-RAY PATTERN | 174021-01 | MEDTECH | OLO | 03760244031785 |
| RED Q-CONNECT NAV REF | 174059-00 | MEDTECH | OLO | 03760244030245 |
| Navigation probe | 174149 | MEDTECH | OLO | 03760244034144 |
| 3D X-RAY PATTERN | 174021 | MEDTECH | OLO | 03760244033383 |
| ROSTAR CLAMP | 174132-02 | MEDTECH | OLO | 03760244034120 |