The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Modification To Verte-stack Spinal System.
| Device ID | K060719 |
| 510k Number | K060719 |
| Device Name: | MODIFICATION TO VERTE-STACK SPINAL SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Edward S Chin |
| Correspondent | Edward S Chin MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-17 |
| Decision Date | 2006-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885074549873 | K060719 | 000 |
| 00885074524764 | K060719 | 000 |
| 00885074524757 | K060719 | 000 |
| 00885074524740 | K060719 | 000 |
| 00885074524733 | K060719 | 000 |
| 00885074524726 | K060719 | 000 |
| 00885074524719 | K060719 | 000 |
| 00885074524702 | K060719 | 000 |
| 00885074524696 | K060719 | 000 |
| 00885074524689 | K060719 | 000 |
| 00885074524771 | K060719 | 000 |
| 00885074524788 | K060719 | 000 |
| 00885074549743 | K060719 | 000 |
| 00885074549866 | K060719 | 000 |
| 00885074549859 | K060719 | 000 |
| 00885074549842 | K060719 | 000 |
| 00885074549835 | K060719 | 000 |
| 00885074549828 | K060719 | 000 |
| 00885074549804 | K060719 | 000 |
| 00885074549798 | K060719 | 000 |
| 00885074549767 | K060719 | 000 |
| 00885074549750 | K060719 | 000 |
| 00885074524672 | K060719 | 000 |