Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K221244
CD Horizon Spinal System · Medtronic · decided 2022-05-25 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CD Horizon™ ModuLeX™ Spinal System | 55946105045 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000971724 |
| CD Horizon™ ModuLeX™ Spinal System | 55901506520 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000965235 |
| CD Horizon™ ModuLeX™ Spinal System | NAV5597625 | MEDTRONIC SOFAMOR DANEK, INC. | HBE OLO | 00763000585976 |
| CD Horizon™ ModuLeX™ Spinal System | 55902506565 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 20763000966021 |
| CD Horizon™ ModuLeX™ Spinal System | 55902504022 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 20763000965352 |
| CD Horizon™ ModuLeX™ Spinal System | 55903505527 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 20763000966434 |
| CD Horizon™ ModuLeX™ Spinal System | 55902504015 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 20763000965338 |
| CD Horizon™ ModuLeX™ Spinal System | 55903505532 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 20763000604879 |
| CD Horizon™ ModuLeX™ Spinal System | 55946004035 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000594343 |
| CD Horizon™ ModuLeX™ Spinal System | 55902505045 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 20763000600062 |
| CD Horizon™ ModuLeX™ Spinal System | 55946205040 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 20763000591728 |
| CD Horizon™ ModuLeX™ Spinal System | 55946105527 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000971748 |
| CD Horizon™ ModuLeX™ Spinal System | 55900504530 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000592172 |
| CD Horizon™ ModuLeX™ Spinal System | 55902505545 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 20763000965789 |
| CD Horizon™ ModuLeX™ Spinal System | 55902505055 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 20763000965680 |
| CD Horizon™ ModuLeX™ Spinal System | 55903504532 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 20763000604633 |
| CD Horizon™ ModuLeX™ Spinal System | 55902504525 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 20763000599885 |
| CD Horizon™ ModuLeX™ Spinal System | 55946206545 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 20763000591902 |
| CD Horizon™ ModuLeX™ Spinal System | 55946104525 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000971571 |
| CD Horizon™ Spinal System | RBT085431 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000845100 |
| CD Horizon™ ModuLeX™ Spinal System | 55901506040 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000599447 |
| CD Horizon™ ModuLeX™ Spinal System | 55901506015 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000599393 |
| CD Horizon™ ModuLeX™ Spinal System | 55901504025 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000598938 |
| CD Horizon™ ModuLeX™ Spinal System | 55946006050 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000594664 |
| CD Horizon™ ModuLeX™ Spinal System | 55946006035 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ NKB | 00763000594633 |