Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K123568
VERTEX RECONSTRUCTION SYSTEM · Medtronic Sofamor Danek USA, Inc. · decided 2012-12-18 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| VERTEX® Reconstruction System | X1111088 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00643169108691 |
| VERTEX® Reconstruction System | X1111085 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00643169108660 |
| VERTEX® Reconstruction System | X1111084 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00643169108653 |
| VERTEX® Reconstruction System | X1111083 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00643169108646 |
| VERTEX® Reconstruction System | X1111086 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00643169108677 |
| VERTEX® Reconstruction System | X1111089 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00643169108707 |
| VERTEX® Reconstruction System | X1111082 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00643169108639 |
| VERTEX® Reconstruction System | X1111087 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00643169108684 |