Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K223494
CD Horizon Spinal System · Medtronic · decided 2023-01-23 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CD Horizon™ ModuLeX™ Spinal System | 55904504545 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000711481 |
| CD Horizon™ ModuLeX™ Spinal System | 55904506545 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000711610 |
| CD Horizon™ ModuLeX™ Spinal System | 55904505550 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000711559 |
| CD Horizon™ ModuLeX™ Spinal System | 55904504540 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000711474 |
| CD Horizon™ ModuLeX™ Spinal System | 55904504530 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000711450 |
| CD Horizon™ ModuLeX™ Spinal System | 55900507545 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000592707 |
| CD Horizon™ ModuLeX™ Spinal System | 55902507535 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000607302 |
| CD Horizon™ ModuLeX™ Spinal System | 55901509550 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000743789 |
| CD Horizon™ ModuLeX™ Spinal System | 55904508555 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000711764 |
| CD Horizon™ ModuLeX™ Spinal System | 55901508540 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000743703 |
| CD Horizon™ ModuLeX™ Spinal System | 55904507545 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000711689 |
| CD Horizon™ ModuLeX™ Spinal System | 55904507555 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000711702 |
| CD Horizon™ ModuLeX™ Spinal System | 55900507550 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000592714 |
| CD Horizon™ ModuLeX™ Spinal System | 55900507560 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000592738 |
| CD Horizon™ ModuLeX™ Spinal System | 55901508560 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000743741 |
| CD Horizon™ ModuLeX™ Spinal System | 55900508555 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000743673 |
| CD Horizon™ ModuLeX™ Spinal System | 55904507535 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000711665 |
| CD Horizon™ ModuLeX™ Spinal System | 55900507555 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000592721 |
| CD Horizon™ ModuLeX™ Spinal System | 55904507525 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000711641 |
| CD Horizon™ ModuLeX™ Spinal System | 55904506525 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000711573 |
| CD Horizon™ ModuLeX™ Spinal System | 55901508535 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000743697 |
| CD Horizon™ ModuLeX™ Spinal System | 55904508545 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000711740 |
| CD Horizon™ ModuLeX™ Spinal System | 55900508540 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000743642 |
| CD Horizon™ ModuLeX™ Spinal System | 55901508530 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000713003 |
| CD Horizon™ ModuLeX™ Spinal System | 55904504535 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000711467 |