Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K201189
Stealthstation S8 Spine Software v1.3.0 · Medtronic Navigation, Inc. · decided 2020-05-29 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| StealthStation S8 Spine | 9735919 | MEDTRONIC NAVIGATION, INC. | OLO | 00763000377939 |
| StealthStation S8 Spine | 9735740 | MEDTRONIC NAVIGATION, INC. | OLO | 00763000378240 |
| Medtronic Navigation | 9735740 | MEDTRONIC NAVIGATION, INC. | OLO | 00763000457204 |
| StealthAiR™ Spine | 9736350 | MEDTRONIC NAVIGATION, INC. | OLO | 00763000385637 |
| StealthAiR™ Spine | 9736350 | MEDTRONIC NAVIGATION, INC. | OLO | 00763000416805 |