Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K211958
CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · decided 2021-07-21 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CD Horizon™ ModuLeX™ Spinal System | G559300145 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000465582 |
| CD Horizon™ ModuLeX™ Spinal System | G559300156 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000465599 |