Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K111264
CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM · Medtronic Sofamor Danek USA · decided 2011-10-12 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CORNERSTONE® PSR Cervical Fusion System | 6273144 | MEDTRONIC SOFAMOR DANEK, INC. | MQP ODP | 00613994157942 |
| CORNERSTONE® PSR Cervical Fusion System | 6274041 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994116314 |
| CORNERSTONE® PSR Cervical Fusion System | 6274011 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994116307 |
| CORNERSTONE® PSR Cervical Fusion System | 6284344 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994367419 |
| CORNERSTONE® PSR Cervical Fusion System | 7270744 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994982230 |
| CORNERSTONE® PSR Cervical Fusion System | 7270941 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994981981 |
| (unnamed) | 6274711 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00763000864491 |
| CORNERSTONE® PSR Cervical Fusion System | 6274711 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994116512 |
| CORNERSTONE® PSR Cervical Fusion System | 7271211 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994982063 |
| (unnamed) | 6274944 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00763000864576 |
| (unnamed) | 6274911 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00763000864552 |
| CORNERSTONE® PSR Cervical Fusion System | 7271144 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994982056 |
| CORNERSTONE® PSR Cervical Fusion System | 6274541 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994116468 |
| (unnamed) | 6274811 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00763000864521 |
| CORNERSTONE® PSR Cervical Fusion System | 7270911 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994981974 |
| CORNERSTONE® PSR Cervical Fusion System | 7270544 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994982179 |
| CORNERSTONE® PSR Cervical Fusion System | 7271244 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994982087 |
| (unnamed) | 6274611 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00763000864460 |
| CORNERSTONE® PSR Cervical Fusion System | 6274941 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994116581 |
| CORNERSTONE® PSR Cervical Fusion System | 6284341 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994366023 |
| CORNERSTONE® PSR Cervical Fusion System | 6274111 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994116338 |
| CORNERSTONE® PSR Cervical Fusion System | 7271044 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994982025 |
| (unnamed) | 6274541 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00763000864446 |
| CORNERSTONE® PSR Cervical Fusion System | 7271011 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994982001 |
| CORNERSTONE® PSR Cervical Fusion System | 7271344 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994982117 |