The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Traverse Oct Spinal Fixation System.
| Device ID | K062447 |
| 510k Number | K062447 |
| Device Name: | TRAVERSE OCT SPINAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Ed Chin |
| Correspondent | Ed Chin MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-22 |
| Decision Date | 2007-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994207661 | K062447 | 000 |
| 00613994207654 | K062447 | 000 |
| 00613994207647 | K062447 | 000 |
| 00613994206374 | K062447 | 000 |
| 00613994205643 | K062447 | 000 |
| 00613994205612 | K062447 | 000 |