Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K201407
CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · decided 2020-09-10 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CD HORIZON® Spinal System | 5599065 | MEDTRONIC SOFAMOR DANEK, INC. | HBE | 00763000279097 |
| CD HORIZON® Spinal System | 55901005535 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000256081 |
| CD HORIZON® Spinal System | 55900007545 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000256050 |
| CD HORIZON® Spinal System | 55901007540 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000256586 |
| CD HORIZON® Spinal System | 55901007535 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000256579 |
| CD HORIZON® Spinal System | 55900006555 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000256043 |
| CD HORIZON® Spinal System | 559200001 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 20763000274454 |
| CD Horizon™ Modular 5.5/6.0mm Spinal System | 5599300 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000279042 |
| CD HORIZON® Spinal System | 55901004545 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000256456 |
| CD HORIZON® Spinal System | 55900007535 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000274115 |
| CD HORIZON® Spinal System | 55900004535 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000273989 |
| CD HORIZON® Spinal System | 55900005555 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000274054 |
| CD HORIZON® Spinal System | 55901004540 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000256074 |
| CD HORIZON® Spinal System | 55901005545 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000256104 |
| CD HORIZON® Spinal System | 55900007560 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000274146 |
| CD HORIZON® Spinal System | 55900007530 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000274108 |
| CD HORIZON® Spinal System | 55900005535 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000255985 |
| CD HORIZON® Spinal System | 55901004535 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000256449 |
| CD Horizon™ Modular 5.5/6.0mm Spinal System | 5599302 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000279226 |
| CD HORIZON® Spinal System | 55900004545 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000273996 |
| CD HORIZON® Spinal System | 55900006540 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000256012 |
| CD HORIZON® Spinal System | 55901004550 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000256463 |
| CD HORIZON® Spinal System | 559200004 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000274436 |
| CD HORIZON® Spinal System | 55901006530 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000256531 |
| CD HORIZON® Spinal System | 55901005560 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000256524 |