Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K094042
PEEK PREVAIL CERVICAL INTERBODY DEVICE · Medtronic Sofamor Danek · decided 2010-06-30 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| (unnamed) | 11000000 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994392756 |
| PEEK PREVAIL™ Cervical Interbody Device | 9010000047 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994645753 |
| (unnamed) | 9195005 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00721902862229 |
| PEEK PREVAIL™ Cervical Interbody Device | 9010000035 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994645975 |
| PEEK PREVAIL™ Cervical Interbody Device | 9010000036 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994645982 |
| (unnamed) | 9195001 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00721902862144 |
| Medtronic Reusable Instruments | 1220222 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994309488 |
| (unnamed) | 9195008 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00721902862366 |
| PEEK PREVAIL™ Cervical Interbody Device | 9010000039 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994646019 |
| Medtronic Reusable Instruments | 1201111 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994309495 |
| (unnamed) | 9195004 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00721902862175 |
| PEEK PREVAIL™ Cervical Interbody Device | 9010000046 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994645746 |
| PEEK PREVAIL™ Cervical Interbody Device | 9010000048 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994645760 |
| PEEK PREVAIL™ Cervical Interbody Device | 9010000038 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994646002 |
| (unnamed) | 9195003 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00721902862168 |
| ZEPHIR® Anterior Cervical System | 8797033 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00721902634376 |
| (unnamed) | 9195007 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00721902862311 |
| PEEK PREVAIL™ Cervical Interbody Device | 9010000045 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994645739 |
| Medtronic Reusable Instruments | 1209999 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994504470 |
| PEEK PREVAIL™ Cervical Interbody Device | 9010000037 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994645999 |
| (unnamed) | 9195002 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00721902862151 |
| (unnamed) | 9195006 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00721902862267 |
| Medtronic Reusable Instruments | 1220777 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994503442 |
| Medtronic Reusable Instruments | 1204444 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994351128 |
| PEEK PREVAIL™ Cervical Interbody Device | 9010000049 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00613994645777 |