Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K162379
CD HORIZON® Spinal System · Medtronic Sofamor Danek USA, Inc. · decided 2016-11-16 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CD HORIZON® SOLERA® Spinal System | 55720005555 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169761629 |
| CD HORIZON® SOLERA® Spinal System | 55720006535 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169761919 |
| CD HORIZON® SOLERA® Spinal System | 55720007555 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169761995 |
| CD HORIZON® SOLERA® Spinal System | 55720005530 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169761865 |
| CD HORIZON® SOLERA® Spinal System | 55720008545 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169763104 |
| Medtronic Transportation/Sterilization Cassette | 5332021 | MEDTRONIC SOFAMOR DANEK, INC. | KCT | 00643169792005 |
| CD HORIZON® SOLERA® Spinal System | 55720007540 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169761964 |
| Medtronic Transportation/Sterilization Cassette | 5332022 | MEDTRONIC SOFAMOR DANEK, INC. | KCT | 00643169792012 |
| Medtronic Transportation/Sterilization Cassette | 5332019 | MEDTRONIC SOFAMOR DANEK, INC. | KCT | 00643169791985 |
| CD HORIZON® SOLERA® Spinal System | 55720005545 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169761896 |
| CD HORIZON® SOLERA® Spinal System | 55720008540 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169763098 |
| CD HORIZON® SOLERA® Spinal System | 55720007545 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169761971 |
| Medtronic Transportation/Sterilization Cassette | 5332018 | MEDTRONIC SOFAMOR DANEK, INC. | KCT | 00643169791978 |
| Medtronic Transportation/Sterilization Cassette | 5332023 | MEDTRONIC SOFAMOR DANEK, INC. | KCT | 00643169792029 |
| Medtronic Transportation/Sterilization Cassette | 5332020 | MEDTRONIC SOFAMOR DANEK, INC. | KCT | 00643169791992 |
| CD HORIZON® SOLERA® Spinal System | 55720006555 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169761957 |
| CD HORIZON® SOLERA® Spinal System | 55720006550 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169761940 |
| CD HORIZON® SOLERA® Spinal System | 55720007550 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169761988 |
| CD HORIZON® SOLERA® Spinal System | 55720005540 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169761889 |
| CD HORIZON® SOLERA® Spinal System | 55720006540 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169761926 |
| CD HORIZON® SOLERA® Spinal System | 55720005535 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169761872 |
| CD HORIZON® SOLERA® Spinal System | 55720008555 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169762015 |
| CD HORIZON® SOLERA® Spinal System | 55720008550 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169762008 |
| CD HORIZON® SOLERA® Spinal System | 55720006530 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169761902 |
| CD HORIZON® SOLERA® Spinal System | 55720005550 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169761612 |