The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc with the FDA for 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™ S.
| Device ID | K192502 |
| 510k 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™ S |
| 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 |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MQP |
| Subsequent Product Code | OVD |
| Subsequent Product Code | PLR |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-12 |
| Decision Date | 2020-01-22 |