Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K171031
CRESCENT Spinal System · Medtronic Sofamor Danek · decided 2017-07-06 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CRESCENT™ Spinal System | X0515002 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169666078 |
| CRESCENT™ Spinal System | X0515004 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169666092 |
| CRESCENT™ Spinal System | X0515005 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169666108 |
| CRESCENT™ Spinal System | X1015073 | MEDTRONIC SOFAMOR DANEK, INC. | KCT | 00643169723368 |
| CRESCENT™ Spinal System | X0515010 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169690905 |
| CRESCENT™ Spinal System | X0515001 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169666061 |
| CRESCENT™ Spinal System | X0415015 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169666023 |
| CRESCENT™ Spinal System | X0415014 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169666016 |
| CRESCENT™ Spinal System | X0515008 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169666139 |
| CRESCENT™ Spinal System | X0515003 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169666085 |
| CRESCENT™ Spinal System | X0415017 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169666047 |
| CRESCENT™ Spinal System | X0415013 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169666009 |
| CRESCENT™ Spinal System | X0415012 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169665996 |
| CRESCENT™ Spinal System | X0515006 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169666115 |
| CRESCENT™ Spinal System | X0415016 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169666030 |
| CRESCENT™ Spinal System | X0515019 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169690912 |
| CRESCENT™ Spinal System | X0415011 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169665989 |
| CRESCENT™ Spinal System | X0415010 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169665972 |
| CRESCENT™ Spinal System | X0515007 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169666122 |
| CRESCENT™ Spinal System | X0415018 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169666054 |
| CRESCENT™ Spinal System | X0515009 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169666146 |