Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| VERTEX® Reconstruction System | X0108016 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994427106 |
| VERTEX® Reconstruction System | X0108029 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994426970 |
| VERTEX® Reconstruction System | 6958924 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994354518 |
| VERTEX® Reconstruction System | 6958916 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994354556 |
| VERTEX® Reconstruction System | 6958720 | MEDTRONIC SOFAMOR DANEK, INC. | KWP NKG | 00613994355010 |
| VERTEX® Reconstruction System | 6958814 | MEDTRONIC SOFAMOR DANEK, INC. | KWP NKG | 00613994354808 |
| VERTEX® Reconstruction System | X0108012 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994427151 |
| VERTEX® Reconstruction System | 6958830 | MEDTRONIC SOFAMOR DANEK, INC. | KWP NKG | 00613994354723 |
| VERTEX® Reconstruction System | 6958914 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994354563 |
| VERTEX® Reconstruction System | 6958820 | MEDTRONIC SOFAMOR DANEK, INC. | KWP NKG | 00613994354778 |
| VERTEX® Reconstruction System | X0108020 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994427045 |
| VERTEX® Reconstruction System | 6958838 | MEDTRONIC SOFAMOR DANEK, INC. | KWP NKG | 00613994354686 |
| VERTEX® Reconstruction System | 6958852 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994354617 |
| VERTEX® Reconstruction System | 6958912 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994354570 |
| VERTEX® Reconstruction System | 6958818 | MEDTRONIC SOFAMOR DANEK, INC. | KWP NKG | 00613994354785 |
| VERTEX® Reconstruction System | 6958928 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994354495 |
| VERTEX® Reconstruction System | 6958840 | MEDTRONIC SOFAMOR DANEK, INC. | KWP NKG | 00613994354679 |
| VERTEX® Reconstruction System | 6958940 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994354433 |
| VERTEX® Reconstruction System | X0108019 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994427076 |
| VERTEX® Reconstruction System | X0108026 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994427007 |
| VERTEX® Reconstruction System | 6958718 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994355027 |
| VERTEX® Reconstruction System | X0108021 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994427069 |
| VERTEX® Reconstruction System | 6958850 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994354624 |
| VERTEX® Reconstruction System | 6958828 | MEDTRONIC SOFAMOR DANEK, INC. | KWP NKG | 00613994354730 |
| VERTEX® Reconstruction System | 6958836 | MEDTRONIC SOFAMOR DANEK, INC. | KWP NKG | 00613994354693 |