The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Elevate Spinal System, Capstone Ptc Spinal System, Crescent Spinal System, Crescent Spinal System Titanium.
| Device ID | K172199 |
| 510k Number | K172199 |
| Device Name: | ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Justin O'connor |
| Correspondent | Justin O'connor Medtronic Sofamor Danek 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 | 2017-07-21 |
| Decision Date | 2017-09-19 |
| Summary: | summary |