Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K143569
CD HORIZON Spinal System · Medtronic Sofamor Danek USA, Inc. · decided 2015-02-12 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CD HORIZON® SOLERA® Spinal System | 5444370 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169206779 |
| CD HORIZON® SOLERA® Spinal System | 5464320 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169207011 |
| CD HORIZON® SOLERA® Spinal System | 5564325 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169207127 |
| CD HORIZON® SOLERA® Spinal System | 5444325 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169206687 |
| CD HORIZON® SOLERA® Spinal System | 5444320 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169206670 |
| CD HORIZON® SOLERA® Spinal System | 5564320 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169207110 |
| CD HORIZON® SOLERA® Spinal System | 5464325 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169207004 |
| (unnamed) | 1850096 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169072640 |
| CD HORIZON® SOLERA® Spinal System | 5564330 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169207134 |
| CD HORIZON® SOLERA® Spinal System | X0715007 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169657267 |
| CD HORIZON® SOLERA® Spinal System | 5564370 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169207219 |
| CD HORIZON® SOLERA® Spinal System | 5554370 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169206977 |
| (unnamed) | 7069093 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169352346 |
| CD HORIZON® SOLERA® Spinal System | 5464370 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169207103 |
| CD HORIZON® SOLERA® Spinal System | 5464335 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169207035 |
| (unnamed) | 7069094 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169357792 |
| CD HORIZON® SOLERA® Spinal System | 5444335 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169206700 |
| CD HORIZON® SOLERA® Spinal System | X0715005 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169657243 |
| CD HORIZON® Spinal System | 7069098 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169542853 |
| CD HORIZON® SOLERA® Spinal System | X0715003 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169657229 |
| CD HORIZON® SOLERA® Spinal System | 5564335 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169207141 |