Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K142591
CD HORIZON Spinal System · Medtronic Sofamor Danek USA, Inc. · decided 2014-12-01 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CD HORIZON® Spinal System | 45410006545 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169428614 |
| CD HORIZON ESSENCE™ Spinal System | 45440007540 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00763000794521 |
| CD HORIZON® Spinal System | 45410006535 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00763000794446 |
| CD HORIZON® Spinal System | 45410005550 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00763000794439 |
| CD HORIZON ESSENCE™ Spinal System | 45440007540 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169428676 |
| CD HORIZON ESSENCE™ Spinal System | 45440004520 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00763000794682 |
| CD HORIZON ESSENCE™ Spinal System | 45440005550 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169428751 |
| CD HORIZON ESSENCE™ Spinal System | 45440004520 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169428836 |
| CD HORIZON ESSENTIALS™ Spinal System | 45340007545 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169428959 |
| CD HORIZON ESSENTIALS™ Spinal System | 4530020 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169428928 |
| CD HORIZON ESSENCE™ Spinal System | 45440006540 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00763000794576 |
| CD HORIZON ESSENCE™ Spinal System | 45440008560 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00763000794491 |
| CD HORIZON ESSENCE™ Spinal System | 45440005540 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169428775 |
| CD HORIZON® Spinal System | 45410006540 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169428607 |
| CD HORIZON ESSENCE™ Spinal System | 4540020 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00763000802134 |
| CD HORIZON ESSENCE™ Spinal System | 45410005540 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169428560 |
| CD HORIZON ESSENCE™ Spinal System | 45440007550 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00763000794507 |
| CD HORIZON® Spinal System | 45410006545 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00763000794460 |
| CD HORIZON® Spinal System | 45410006550 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00763000794477 |
| CD HORIZON ESSENTIALS™ Spinal System | 45340006540 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169429062 |
| CD HORIZON® Spinal System | 45410006540 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00763000794453 |
| CD HORIZON ESSENCE™ Spinal System | 45440008560 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169428645 |
| CD HORIZON ESSENCE™ Spinal System | 45440005540 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00763000794620 |
| CD HORIZON ESSENCE™ Spinal System | 45440004535 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00763000794675 |
| CD HORIZON ESSENCE™ Spinal System | 45440004540 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00763000794668 |