Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K091797
TSRH SPINAL SYSTEM · Medtronic Sofamor Danek · decided 2010-04-30 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| TSRH® Spinal System | X0209494 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994576507 |
| TSRH® Spinal System | 83545609H | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994888228 |
| TSRH® Spinal System | 83545459H | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994888198 |
| TSRH® Spinal System | 83575609H | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994888037 |
| TSRH® Spinal System | X0209503 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994576811 |
| TSRH® Spinal System | 83585609H | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994888129 |
| TSRH® Spinal System | 83545259H | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994888150 |
| TSRH® Spinal System | 83575359H | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994887986 |
| TSRH® Spinal System | X0209475 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994577092 |
| TSRH® Spinal System | X0209491 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994576538 |
| TSRH® Spinal System | X0209458 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994577269 |
| TSRH® Spinal System | X0209496 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994576484 |
| TSRH® Spinal System | X0209483 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994576613 |
| TSRH® Spinal System | X0209508 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994576767 |
| TSRH® Spinal System | X0209515 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994576699 |
| TSRH® Spinal System | 83545209H | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994888143 |
| TSRH® Spinal System | 83575309H | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994887979 |
| TSRH® Spinal System | X0209493 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994576514 |
| TSRH® Spinal System | 83565309H | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994888341 |
| TSRH® Spinal System | X0209482 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994576620 |
| TSRH® Spinal System | X0209498 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994576866 |
| TSRH® Spinal System | X0209481 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994576637 |
| TSRH® Spinal System | X0209436 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994577085 |
| TSRH® Spinal System | X0209488 | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994576569 |
| TSRH® Spinal System | 83565409H | MEDTRONIC SOFAMOR DANEK, INC. | KWP MNH MNI NKB | 00613994888136 |