Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K143019
CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · decided 2015-04-08 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CD HORIZON® Spinal System | X1013185 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169465824 |
| CD HORIZON® Spinal System | X1013194 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169465732 |
| CD HORIZON® Spinal System | X1013192 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169465756 |
| CD HORIZON® Spinal System | X1013216 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169468771 |
| CD HORIZON® Spinal System | X1013191 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169465763 |
| CD HORIZON® Spinal System | X1013213 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169468740 |
| CD HORIZON® Spinal System | X1013188 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169465794 |
| CD HORIZON® Spinal System | X1013211 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169468726 |
| CD HORIZON® Spinal System | X1013195 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169465725 |
| CD HORIZON® Spinal System | X1013177 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169465909 |
| CD HORIZON® Spinal System | X1013189 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169465787 |
| CD HORIZON® Spinal System | X1013186 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169465817 |
| CD HORIZON® Spinal System | X1013184 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169465831 |
| CD HORIZON® Spinal System | X1013182 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169465855 |
| CD HORIZON® Spinal System | X1013190 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169465770 |
| CD HORIZON® Spinal System | X1013199 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169465688 |
| CD HORIZON® Spinal System | X1013205 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169468665 |
| Medtronic Reusable Instruments | X1013178 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169465893 |
| CD HORIZON® Spinal System | X1013207 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169468689 |
| CD HORIZON® Spinal System | X1013183 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169465848 |
| CD HORIZON® Spinal System | X1013196 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169465718 |
| CD HORIZON® Spinal System | X1013212 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169468733 |
| CD HORIZON® Spinal System | X1013193 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169465749 |
| CD HORIZON® Spinal System | X1013197 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169465701 |
| CD HORIZON® Spinal System | X1013181 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169465862 |