Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K233951
CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) · Medtronic Sofamor Danek USA, Inc. · decided 2024-03-27 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CD Horizon™ ModuLeX™ Spinal System | 55901619500 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000858568 |
| CD Horizon™ ModuLeX™ Spinal System | 55901610210 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000858414 |
| CD Horizon™ ModuLeX™ Spinal System | 55901600390 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000859084 |
| CD Horizon™ ModuLeX™ Spinal System | 55901617580 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000858506 |
| CD Horizon™ ModuLeX™ Spinal System | 55901617570 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000858490 |
| CD Horizon™ ModuLeX™ Spinal System | 55901600300 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000859053 |
| CD Horizon™ ModuLeX™ Spinal System | 55900610190 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000859251 |
| CD Horizon™ ModuLeX™ Spinal System | 55901619510 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000858575 |
| CD Horizon™ ModuLeX™ Spinal System | 55901610180 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000858384 |
| CD Horizon™ ModuLeX™ Spinal System | 55900610100 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000859213 |
| CD Horizon™ ModuLeX™ Spinal System | 55900618500 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000859305 |
| CD Horizon™ ModuLeX™ Spinal System | 55901610170 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000858377 |
| CD Horizon™ ModuLeX™ Spinal System | 55901618590 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000858551 |
| CD Horizon™ ModuLeX™ Spinal System | 55900600110 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000861391 |
| CD Horizon™ ModuLeX™ Spinal System | 55901618570 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000858537 |
| CD Horizon™ ModuLeX™ Spinal System | 55900617570 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000859275 |
| CD Horizon™ ModuLeX™ Spinal System | 55900608580 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000861490 |
| CD Horizon™ ModuLeX™ Spinal System | 55901619590 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000858605 |
| CD Horizon™ ModuLeX™ Spinal System | 55900607580 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000861452 |
| CD Horizon™ ModuLeX™ Spinal System | 559200082 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000859398 |
| CD Horizon™ ModuLeX™ Spinal System | 55900618570 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000859312 |
| CD Horizon™ ModuLeX™ Spinal System | 55900617550 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000891459 |
| CD Horizon™ ModuLeX™ Spinal System | 55901610110 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000858360 |
| CD Horizon™ ModuLeX™ Spinal System | 55900608510 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000891367 |
| CD Horizon™ ModuLeX™ Spinal System | 55901600380 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000859077 |