Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record P000058
Device name not on record · Medtronic Sofamor Danek USA, Inc. · decided 2010-01-20 (APPR)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Clydesdale™ Spinal System | 2922645 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00613994972408 |
| Clydesdale™ Spinal System | 2969040 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00613994485625 |
| INFUSE® Bone Graft | 7510200 | MEDTRONIC SOFAMOR DANEK, INC. | NEK NPZ | 00681490843782 |
| INTER FIX™ RP Threaded Fusion Device | 9011225 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00673978957357 |
| INTER FIX™ Threaded Fusion Device | 890-160 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00673978072081 |
| Clydesdale™ Spinal System | 2969640 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00613994485731 |
| Clydesdale™ Spinal System | 2968445 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00613994485762 |
| Clydesdale™ Spinal System | 2968440 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00613994485779 |
| INTER FIX™ Threaded Fusion Device | 890-209 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00673978072319 |
| Clydesdale™ Spinal System | 2926240 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00613994972316 |
| Clydesdale™ Spinal System | 2969240 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00613994485571 |
| Clydesdale™ Spinal System | 2922050 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00613994972903 |
| Clydesdale™ Spinal System | 2922445 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00613994972453 |
| INTER FIX™ RP Threaded Fusion Device | 9012223 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00673978957531 |
| Clydesdale™ Spinal System | 2968845 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00613994485922 |
| Clydesdale™ Spinal System | 2968060 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00613994485830 |
| Clydesdale™ Spinal System | 2926645 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00613994972569 |
| INTER FIX™ RP Threaded Fusion Device | 9012023 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00673978957494 |
| Clydesdale™ Spinal System | 2968655 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00613994485953 |
| PERIMETER® Interbody Fusion Device | 3492316 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00613994206787 |
| Clydesdale™ Spinal System | 2922040 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00613994972927 |
| PERIMETER® Interbody Fusion Device | 3492308 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00613994206749 |
| Clydesdale™ Spinal System | 2968860 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00613994485892 |
| Clydesdale™ Spinal System | 2968050 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00613994485854 |
| INTER FIX™ RP Threaded Fusion Device | 9011423 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00673978957371 |