The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Verte-stack Spinal System.
| Device ID | K031780 |
| 510k Number | K031780 |
| Device Name: | VERTE-STACK SPINAL SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Treharne |
| Correspondent | Richard Treharne 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 | 2003-06-10 |
| Decision Date | 2003-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902703966 | K031780 | 000 |
| 00721902703492 | K031780 | 000 |
| 00721902703485 | K031780 | 000 |
| 00885074308647 | K031780 | 000 |
| 00885074204420 | K031780 | 000 |
| 00885074204413 | K031780 | 000 |
| 00885074204406 | K031780 | 000 |
| 00885074204390 | K031780 | 000 |
| 00885074204376 | K031780 | 000 |
| 00885074204369 | K031780 | 000 |
| 00885074204352 | K031780 | 000 |
| 00721902703515 | K031780 | 000 |
| 00721902703843 | K031780 | 000 |
| 00721902703850 | K031780 | 000 |
| 00721902703959 | K031780 | 000 |
| 00721902703942 | K031780 | 000 |
| 00721902703935 | K031780 | 000 |
| 00721902703928 | K031780 | 000 |
| 00721902703911 | K031780 | 000 |
| 00721902703904 | K031780 | 000 |
| 00721902703898 | K031780 | 000 |
| 00721902703881 | K031780 | 000 |
| 00721902703874 | K031780 | 000 |
| 00721902703867 | K031780 | 000 |
| 00885074204307 | K031780 | 000 |