The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc with the FDA for Artic-l 3d Ti Spinal System With Tionic Technology, Artic-xl 3d Ti Spinal System With Tionic Technology.
| Device ID | K190959 |
| 510k Number | K190959 |
| Device Name: | ARTiC-L 3D Ti Spinal System With TiONIC Technology, ARTiC-XL 3D Ti Spinal System With TiONIC Technology |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Medtronic Sofamor Danek USA, Inc 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Emmarie Halteman |
| Correspondent | Emmarie Halteman Medtronic Sofamor Danek USA, Inc 1800 Pyramid Place Memphis, TN 38132 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-12 |
| Decision Date | 2019-07-03 |