Medtronic Sofamor Danek USA, Inc. · Class II · Cleared Jan 22, 2020
| K-number | K192502 |
| Device name | Anatomic PEEK Cervical Fusion System, Anatomic PEEK PTC Cervical Fusion System, Capstone Spinal System, Capstone PTC Spinal System, Capstone Control Spinal System, Capstone Control PTC Spinal System, Clydesdale Spinal System, Clydesdale PTC Spinal System, Cornerstone PSR Cervical Fusion System, Crescent Spinal System, Crescent Spinal System Titanium, Divergence Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L Anterior/Oblique Lumbar Fus |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Product code | MAX |
| Device class | Class II |
| Decision date | Jan 22, 2020 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
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