The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Fuse Spinal System.
| Device ID | K171468 |
| 510k Number | K171468 |
| Device Name: | FUSE Spinal System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Medtronic Sofamor Danek 1800 Pyramid Pl. Memphis, TN 38125 |
| Contact | Ankit K. Shah |
| Correspondent | Ankit K. Shah Medtronic Sofamor Danek 1800 Pyramid Pl. Memphis, TN 38125 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-18 |
| Decision Date | 2017-06-13 |
| Summary: | summary |