Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K132471
CD HORIZON SPINAL SYSTEM · Medtronic Sofamor Danek USA, Inc. · decided 2013-10-08 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CD HORIZON® Spinal System | 5541113 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169348134 |
| CD HORIZON® Spinal System | 5541322 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169347960 |
| CD HORIZON® Spinal System | 5541112 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169348127 |
| CD HORIZON® Spinal System | 5541114 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169348141 |
| CD HORIZON® Spinal System | 5541189 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169348059 |
| CD HORIZON® Spinal System | 5541191 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169348035 |
| CD HORIZON® Spinal System | 5541172 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169348219 |
| CD HORIZON® Spinal System | 5541173 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169348226 |
| CD HORIZON® Spinal System | 5541312 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169347984 |
| CD HORIZON® Spinal System | 5541302 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169348004 |
| CD HORIZON® Spinal System | 5541123 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169348165 |
| CD HORIZON® Spinal System | 5541133 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169348189 |
| CD HORIZON® Spinal System | 5541188 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169348066 |
| (unnamed) | 5584119 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169354197 |
| CD HORIZON® Spinal System | 5541143 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169348202 |
| CD HORIZON® Spinal System | 5541122 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169348158 |
| CD HORIZON® Spinal System | 5541102 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169348097 |
| CD HORIZON® Spinal System | 5541190 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169348042 |
| CD HORIZON® Spinal System | 5541103 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169348103 |
| CD HORIZON® Spinal System | 5541303 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169347991 |
| CD HORIZON® Spinal System | 5541104 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169348110 |
| CD HORIZON® Spinal System | 5541199 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169348011 |
| CD HORIZON® Spinal System | 5541313 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169347977 |
| CD HORIZON® Spinal System | 5541124 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169348172 |
| CD HORIZON® Spinal System | 5541101 | MEDTRONIC SOFAMOR DANEK, INC. | KWP KWQ MNH MNI NKB OSH | 00643169348080 |