The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Capstone R Spinal System.
| Device ID | K103731 |
| 510k Number | K103731 |
| Device Name: | CAPSTONE R SPINAL SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Thao Phan |
| Correspondent | Thao Phan 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 | 2010-12-22 |
| Decision Date | 2011-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994846266 | K103731 | 000 |
| 00613994803061 | K103731 | 000 |
| 00763000096908 | K103731 | 000 |
| 00763000096892 | K103731 | 000 |
| 00763000096885 | K103731 | 000 |
| 00763000096878 | K103731 | 000 |
| 00763000096915 | K103731 | 000 |