Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K214011
Catalyft PL Expandable Interbody System Navigated Instruments, Anteralign TL Spinal System with Titan nanoLOCK Surface Technology Navigated Instruments, and CD Horizon Solera Voyager Spinal System Navigated, Guided, and Powered Drivers · Medtronic Sofamor Danek USA, Inc. · decided 2022-02-09 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Anteralign Spinal System with Titan nanoLock Surface technology | 46813812 | MEDTRONIC SOFAMOR DANEK, INC. | MAX OLO OVD | 00763000193843 |
| Catalyft PL Expandable Interbody System | NAV6061013 | MEDTRONIC SOFAMOR DANEK, INC. | OLO | 00763000292195 |
| Anteralign Spinal System with Titan nanoLock Surface technology | 46813814 | MEDTRONIC SOFAMOR DANEK, INC. | MAX OLO OVD | 00763000193850 |
| Anteralign Spinal System with Titan nanoLock Surface technology | 46813612 | MEDTRONIC SOFAMOR DANEK, INC. | MAX OLO OVD | 00763000193805 |
| Anteralign Spinal System with Titan nanoLock Surface technology | 46813614 | MEDTRONIC SOFAMOR DANEK, INC. | MAX OLO OVD | 00763000198473 |
| Anteralign Spinal System with Titan nanoLock Surface technology | 46812608 | MEDTRONIC SOFAMOR DANEK, INC. | MAX OLO OVD | 00763000193713 |
| Anteralign Spinal System with Titan nanoLock Surface technology | 46812614 | MEDTRONIC SOFAMOR DANEK, INC. | MAX OLO OVD | 00763000193744 |
| Catalyft PL Expandable Interbody System | NAV6061116 | MEDTRONIC SOFAMOR DANEK, INC. | MAX OLO | 00763000255268 |
| Anteralign Spinal System with Titan nanoLock Surface technology | 46813214 | MEDTRONIC SOFAMOR DANEK, INC. | MAX OLO OVD | 00763000193836 |
| Anteralign Spinal System with Titan nanoLock Surface technology | 46813212 | MEDTRONIC SOFAMOR DANEK, INC. | MAX OLO OVD | 00763000193829 |
| Anteralign Spinal System with Titan nanoLock Surface technology | 46813816 | MEDTRONIC SOFAMOR DANEK, INC. | MAX OLO OVD | 00763000193867 |
| Catalyft PL Expandable Interbody System | NAV6062076 | MEDTRONIC SOFAMOR DANEK, INC. | MAX OLO | 00763000255275 |
| Anteralign Spinal System with Titan nanoLock Surface technology | 46812610 | MEDTRONIC SOFAMOR DANEK, INC. | MAX OLO OVD | 00763000193720 |
| Catalyft PL Expandable Interbody System | 6061001 | MEDTRONIC SOFAMOR DANEK, INC. | MAX OLO | 00763000253547 |
| Catalyft PL Expandable Interbody System | NAV6062116 | MEDTRONIC SOFAMOR DANEK, INC. | MAX OLO | 00763000255299 |
| CD HORIZON® SOLERA® VOYAGER™ Spinal System | RBT036401 | MEDTRONIC SOFAMOR DANEK, INC. | HBE OLO | 00763000611279 |
| Catalyft PL Expandable Interbody System | NAV6062096 | MEDTRONIC SOFAMOR DANEK, INC. | MAX OLO | 00763000255282 |
| Anteralign Spinal System with Titan nanoLock Surface technology | 46813210 | MEDTRONIC SOFAMOR DANEK, INC. | MAX OLO OVD | 00763000193812 |
| Catalyft PL Expandable Interbody System | NAV6061096 | MEDTRONIC SOFAMOR DANEK, INC. | MAX OLO | 00763000255251 |
| Catalyft PL Expandable Interbody System | NAV6061000 | MEDTRONIC SOFAMOR DANEK, INC. | MAX OLO | 00763000255237 |
| Anteralign Spinal System with Titan nanoLock Surface technology | 46813416 | MEDTRONIC SOFAMOR DANEK, INC. | MAX OLO OVD | 00763000193881 |
| Anteralign Spinal System with Titan nanoLock Surface technology | 46812214 | MEDTRONIC SOFAMOR DANEK, INC. | MAX OLO OVD | 00763000193775 |
| Anteralign Spinal System with Titan nanoLock Surface technology | 46813608 | MEDTRONIC SOFAMOR DANEK, INC. | MAX OLO OVD | 00763000193782 |
| Anteralign Spinal System with Titan nanoLock Surface technology | 46812212 | MEDTRONIC SOFAMOR DANEK, INC. | MAX OLO OVD | 00763000193768 |
| CD HORIZON® SOLERA® VOYAGER™ Spinal System | RBT036402 | MEDTRONIC SOFAMOR DANEK, INC. | HBE OLO | 00763000611286 |