Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K182121
CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition · Medtronic Sofamor Danek USA, Inc. · decided 2018-11-02 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CD HORIZON® Spinal System | RBT052102 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000082192 |
| CD HORIZON® Spinal System | RBT012202 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000082086 |
| CD HORIZON® Spinal System | RBT034202 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000140427 |
| CD HORIZON® Spinal System | RBT052202 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000082154 |
| CD HORIZON® Spinal System | RBT024102 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000140373 |
| CD HORIZON® Spinal System | RBT023202 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000011277 |
| CD HORIZON® Spinal System | RBT011209 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000023676 |
| CD HORIZON® Spinal System | RBT011210 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000082246 |
| CD HORIZON® Spinal System | RBT011206 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000023645 |
| CD HORIZON® Spinal System | RBT024502 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000374082 |
| CD HORIZON® Spinal System | RBT011204 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000023621 |
| CD HORIZON® Spinal System | RBT023201 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000011260 |
| CD HORIZON® Spinal System | RBT090000 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000082376 |
| CD HORIZON® Spinal System | RBT051211 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000082314 |
| CD HORIZON® Spinal System | RBT023101 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000011246 |
| CD HORIZON® Spinal System | RBT051206 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000023744 |
| CD HORIZON® Spinal System | RBT090004 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000082383 |
| CD HORIZON® Spinal System | RBT033302 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000011284 |
| CD HORIZON® Spinal System | RBT034502 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000374105 |
| CD HORIZON® Spinal System | RBT011009 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000023737 |
| CD HORIZON® Spinal System | RBT024101 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000140380 |
| CD HORIZON® Spinal System | RBT011008 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000023720 |
| CD HORIZON® Spinal System | RBT023301 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000011239 |
| CD HORIZON® Spinal System | RBT062401 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000306809 |
| CD HORIZON® Spinal System | RBT090012 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000159603 |