Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K231184
CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · decided 2023-05-26 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CD Horizon™ ModuLeX™ Spinal System | RBT073201 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000586034 |
| CD Horizon™ ModuLeX™ Spinal System | RBT073202 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000586027 |
| CD Horizon™ ModuLeX™ Spinal System | RBT019220 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000586003 |