The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for T2 Sceptor Spinal System.
| Device ID | K063491 |
| 510k Number | K063491 |
| Device Name: | T2 SCEPTOR SPINAL SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Christine Seifert |
| Correspondent | Christine Seifert MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-17 |
| Decision Date | 2007-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994218872 | K063491 | 000 |
| 00613994218780 | K063491 | 000 |
| 00613994218797 | K063491 | 000 |
| 00613994218803 | K063491 | 000 |
| 00613994218810 | K063491 | 000 |
| 00613994218827 | K063491 | 000 |
| 00613994218834 | K063491 | 000 |
| 00613994218841 | K063491 | 000 |
| 00613994218858 | K063491 | 000 |
| 00613994218773 | K063491 | 000 |