The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa with the FDA for Capstone L Spinal System.
| Device ID | K123978 |
| 510k Number | K123978 |
| Device Name: | CAPSTONE L SPINAL SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | MEDTRONIC SOFAMOR DANEK USA 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Lauren Kamer |
| Correspondent | Lauren Kamer MEDTRONIC SOFAMOR DANEK USA 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 | 2012-12-26 |
| Decision Date | 2013-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169133334 | K123978 | 000 |
| 00643169132955 | K123978 | 000 |
| 00643169133013 | K123978 | 000 |
| 00643169133020 | K123978 | 000 |
| 00643169133037 | K123978 | 000 |
| 00643169133099 | K123978 | 000 |
| 00643169133105 | K123978 | 000 |
| 00643169133112 | K123978 | 000 |
| 00643169133174 | K123978 | 000 |
| 00643169133181 | K123978 | 000 |
| 00643169133198 | K123978 | 000 |
| 00643169132948 | K123978 | 000 |