The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Usa Inc. with the FDA for Capstone Spinal System, Clydesdale Ptc Spinal System, Crescent Spinal System, Crescent Spinal System Titanium, Divergence-l Anterior/oblique Lumbar Fusion System.
| Device ID | K191788 |
| 510k Number | K191788 |
| Device Name: | CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Medtronic Sofamor Danek, USA Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Mia Wiggins |
| Correspondent | Mia Wiggins 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 | 2019-07-03 |
| Decision Date | 2020-03-23 |