Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K121191
VERTEX RCCONSTRUCTION SYSTEM · Medtronic Sofamor Danek, Inc. · decided 2012-06-29 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| VERTEX® Reconstruction System | X0508075 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994531759 |
| CD HORIZON® Spinal System | X0508080 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994531803 |
| VERTEX® Reconstruction System | X0508076 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994531766 |
| VERTEX® Reconstruction System | X0508077 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994531773 |
| VERTEX® Reconstruction System | X0508079 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994531797 |
| VERTEX® Reconstruction System | X0508078 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00613994531780 |