Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K100976
T2 XVBR 1.5 SPINAL SYSTEM · Medtronic Sofamor Danek USA, Inc. · decided 2010-10-21 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Medtronic Reusable Instruments | 9411600 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994683588 |
| T2™ Spinal System | 9392237 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994676566 |
| T2™ Spinal System | 9391947 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994676610 |
| (unnamed) | 9396008 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994840820 |
| Medtronic Reusable Instruments | 9411606 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994730152 |
| (unnamed) | 9396009 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994888372 |
| T2™ Spinal System | 9391623 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994676436 |
| T2™ Spinal System | 9392268 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994676542 |
| Medtronic Reusable Instruments | 9411200 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994730275 |
| Medtronic Reusable Instruments | 9411602 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994730190 |
| Medtronic Reusable Instruments | 9411906 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994730091 |
| (unnamed) | 9396012 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994792532 |
| Medtronic Reusable Instruments | 9401200 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994683601 |
| T2™ Spinal System | 9391969 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994676603 |
| T2™ Spinal System | 9391319 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994676504 |
| Medtronic Reusable Instruments | 9412500 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994683557 |
| T2™ Spinal System | 9392548 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994676238 |
| Medtronic Reusable Instruments | 9411905 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994730107 |
| T2™ Spinal System | 9392225 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994676580 |
| Medtronic Reusable Instruments | 9411301 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994730268 |
| Medtronic Reusable Instruments | 9411300 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994683595 |
| Medtronic Reusable Instruments | 9411900 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994683571 |
| Medtronic Reusable Instruments | 9411903 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994730121 |
| (unnamed) | 9396001 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994792471 |
| Medtronic Reusable Instruments | 9411304 | MEDTRONIC SOFAMOR DANEK, INC. | MQP | 00613994730237 |