Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K153463
CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · decided 2015-12-30 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CD HORIZON Spinal System | 6641170 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576940 |
| CD HORIZON Spinal System | 6641185 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576971 |
| CD HORIZON Spinal System | 6641155 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576919 |
| CD HORIZON Spinal System | 6641095 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576841 |
| CD HORIZON Spinal System | 6641150 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576902 |
| CD HORIZON Spinal System | 6641070 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576797 |
| CD HORIZON Spinal System | 6641050 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576759 |
| CD HORIZON Spinal System | 6641065 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576780 |
| CD HORIZON Spinal System | 6641060 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576773 |
| CD HORIZON Spinal System | 6641165 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576933 |
| CD HORIZON Spinal System | 6641080 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576810 |
| CD HORIZON Spinal System | 6641190 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576988 |
| CD HORIZON Spinal System | 6641055 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576766 |
| CD HORIZON Spinal System | 6641140 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576889 |
| CD HORIZON Spinal System | 6641160 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576926 |
| CD HORIZON Spinal System | 6641010 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576728 |
| CD HORIZON Spinal System | 6641090 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576834 |
| CD HORIZON Spinal System | 6641180 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576964 |
| CD HORIZON Spinal System | 6641145 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576896 |
| CD HORIZON Spinal System | 6641075 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576803 |
| CD HORIZON Spinal System | 6641040 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576735 |
| CD HORIZON Spinal System | 6641175 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576957 |
| CD HORIZON Spinal System | 6641105 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576865 |
| CD HORIZON Spinal System | 6641100 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576858 |
| CD HORIZON Spinal System | 6641110 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OSH | 00643169576872 |