Capstone Control™ Spinal System
Intervertebral Fusion Device With Bone Graft, Lumbar
Medtronic Sofamor Danek USA, INC.
The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Capstone Control™ Spinal System.
Pre-market Notification Details
| Device ID | K190165 |
| 510k Number | K190165 |
| Device Name: | Capstone Control™ Spinal System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Medtronic Sofamor Danek USA, INC. 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Justin O'connor |
| Correspondent | Justin O'connor 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 | 2019-01-31 |
| Decision Date | 2019-05-06 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000121303 | K190165 | 000 |
| 00763000121310 | K190165 | 000 |
| 00763000121327 | K190165 | 000 |
| 00763000121334 | K190165 | 000 |
| 00763000121341 | K190165 | 000 |
| 00763000121358 | K190165 | 000 |
| 00763000121365 | K190165 | 000 |
| 00763000121372 | K190165 | 000 |
| 00763000121389 | K190165 | 000 |
| 00763000121396 | K190165 | 000 |
| 00763000121402 | K190165 | 000 |
| 00763000121419 | K190165 | 000 |
| 00763000121426 | K190165 | 000 |
| 00763000121433 | K190165 | 000 |
| 00763000121440 | K190165 | 000 |
| 00763000121457 | K190165 | 000 |
| 00763000121464 | K190165 | 000 |
| 00763000121297 | K190165 | 000 |
Trademark Results [Capstone Control]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CAPSTONE CONTROL 85253149 4324898 Live/Registered |
Medtronic, Inc. 2011-02-28 |
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