Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K130646
CD HORIZON SPINAL SYSTEM · Medtronic Sofamor Danek USA, Inc. · decided 2013-04-10 (SESU)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CD HORIZON® Spinal System | X0212546 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169607064 |
| CD HORIZON® Spinal System | X0812272 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169372085 |
| CD HORIZON® Spinal System | X0812161 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169355170 |
| CD HORIZON® Spinal System | X0312339 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169180376 |
| CD HORIZON® Spinal System | X0312236 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169180000 |
| CD HORIZON® Spinal System | X0812182 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169355422 |
| CD HORIZON® Spinal System | X0212604 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169184756 |
| CD HORIZON® Spinal System | X0312265 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169179714 |
| CD HORIZON® Spinal System | X0812244 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169371804 |
| CD HORIZON® Spinal System | X0812104 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169355552 |
| CD HORIZON® Spinal System | X0812098 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169334090 |
| CD HORIZON® Spinal System | X0212602 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169184770 |
| CD HORIZON® Spinal System | X0312421 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169179554 |
| CD HORIZON® Spinal System | X0312447 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169179295 |
| CD HORIZON® Spinal System | X0212549 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169607095 |
| CD HORIZON® Spinal System | X0812047 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169355668 |
| CD HORIZON® Spinal System | X0312313 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169180635 |
| CD HORIZON® Spinal System | X0312303 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169180598 |
| CD HORIZON® Spinal System | X0312405 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169179431 |
| CD HORIZON® Spinal System | X0312364 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169179004 |
| CD HORIZON® Spinal System | X0212587 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169607163 |
| CD HORIZON® Spinal System | X0212513 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169606951 |
| CD HORIZON® Spinal System | X0812227 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169372450 |
| CD HORIZON® Spinal System | X0812040 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169355736 |
| CD HORIZON® Spinal System | X0212691 | MEDTRONIC SOFAMOR DANEK, INC. | KWP | 00643169185067 |