Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K153442
CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems · Medtronic Sofamor Danek USA, Inc. · decided 2016-02-18 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CD HORIZON® Spinal System | 25840019570 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169413214 |
| CD HORIZON® Spinal System | 25740018510 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169414846 |
| CD HORIZON® Spinal System | 25530011260 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169414594 |
| CD HORIZON® Spinal System | 25740011210 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169415232 |
| CD HORIZON® Spinal System | 25530017560 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169414105 |
| CD HORIZON® Spinal System | 25630018510 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169412644 |
| CD HORIZON® Spinal System | 25840011014 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169412965 |
| CD HORIZON® Spinal System | 25840019560 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169413207 |
| CD HORIZON® Spinal System | 25630011011 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169412279 |
| CD HORIZON® Spinal System | NAV1065 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169415362 |
| CD HORIZON® Spinal System | 25530018560 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169414198 |
| CD HORIZON® Spinal System | 25530018511 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169414150 |
| CD HORIZON® Spinal System | 25840011290 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169413030 |
| CD HORIZON® Spinal System | 25740017511 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169414785 |
| CD HORIZON® Spinal System | 25000105 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169414648 |
| CD HORIZON® Spinal System | 25530019550 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169414273 |
| CD HORIZON® Spinal System | 25530011290 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169414068 |
| CD HORIZON® Spinal System | 25840011170 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169413290 |
| CD HORIZON® Spinal System | 25530011014 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169414372 |
| CD HORIZON® Spinal System | 25530019512 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169414259 |
| CD HORIZON® Spinal System | NAV0200 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169440241 |
| CD HORIZON® Spinal System | 25740011260 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169415294 |
| CD HORIZON® Spinal System | 25840019512 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169412859 |
| CD HORIZON® Spinal System | 25630011070 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169412248 |
| CD HORIZON® Spinal System | 25740011070 | MEDTRONIC SOFAMOR DANEK, INC. | HWE KWP KWQ MNH MNI NKB OLO OSH | 00643169415102 |