Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| VERTEX® Reconstruction System | X0412232 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00643169176621 |
| VERTEX® Reconstruction System | X0412234 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00643169176607 |
| VERTEX® Reconstruction System | X1211092 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00643169115019 |
| VERTEX® Reconstruction System | 6958844PT | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994358165 |
| VERTEX® Reconstruction System | 7751748PT | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994459374 |
| VERTEX® Reconstruction System | 6958746PT | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994356666 |
| VERTEX® Reconstruction System | X0412241 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00643169176539 |
| VERTEX® Reconstruction System | 7756067 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994448798 |
| VERTEX® Reconstruction System | X0412237 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00643169176577 |
| VERTEX® Reconstruction System | 7751816EP | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994461124 |
| VERTEX® Reconstruction System | X0412236 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00643169176584 |
| VERTEX® Reconstruction System | 7751930PT | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994460400 |
| VERTEX® Reconstruction System | 7751846PT | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994460219 |
| VERTEX® Reconstruction System | X1211114 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00643169115071 |
| VERTEX® Reconstruction System | 7751826PT | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994460295 |
| VERTEX® Reconstruction System | 7751138EP | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994459299 |
| VERTEX® Reconstruction System | 6958750 | MEDTRONIC SOFAMOR DANEK, INC. | KWP NKG | 00613994354860 |
| VERTEX® Reconstruction System | 7751120EP | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994459695 |
| VERTEX® Reconstruction System | X1211137 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00643169114845 |
| VERTEX® Reconstruction System | X0811256 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00643169080782 |
| VERTEX® Reconstruction System | 7751728EP | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994461605 |
| VERTEX® Reconstruction System | 7751838 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994461599 |
| VERTEX® Reconstruction System | 7751146PT | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994459817 |
| VERTEX® Reconstruction System | 6958840PT | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994358189 |
| VERTEX® Reconstruction System | X1211096 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00643169114975 |