Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K171689
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology · Medtronic Sofamor Danek USA, Inc. · decided 2017-10-05 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology | 56251510 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00763000085735 |
| ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology | 56251210 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169801301 |
| ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology | 53301825 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169800472 |
| ARTiC-XL™ Spinal System | 54501835 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169838123 |
| ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology | 5330008 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169762060 |
| ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology | 56351020 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00763000086244 |
| ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology | 56301310 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00763000085797 |
| ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology | 5251220 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169790988 |
| ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology | 5251020 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00763000086039 |
| ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology | 56251110 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169801295 |
| ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology | 56251320 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00763000086152 |
| ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology | 56301505 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00763000085575 |
| ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology | 56351010 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169801448 |
| ARTiC-XL™ 3D Ti Spinal System with TiONIC™ Technology | 53301535 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169800489 |
| ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology | 56351505 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00763000085650 |
| ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology | 56301205 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00763000085544 |
| ARTiC-XL™ Spinal System | 54401535 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169838062 |
| ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology | 56351005 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169801202 |
| ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology | 56250905 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169801011 |
| ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology | 56351110 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00763000085858 |
| ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology | 5251305 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169790858 |
| ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology | 56251205 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00763000085469 |
| ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology | 56251020 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00643169800601 |
| ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology | 5332033 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00763000086329 |
| ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology | 56301320 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00763000086213 |