The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Verte-stack Spinal System.
| Device ID | K021791 |
| 510k Number | K021791 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-31 |
| Decision Date | 2002-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902842740 | K021791 | 000 |
| 00721902379871 | K021791 | 000 |
| 00721902379864 | K021791 | 000 |
| 00721902379802 | K021791 | 000 |
| 00721902379772 | K021791 | 000 |
| 00721902379741 | K021791 | 000 |
| 00721902379727 | K021791 | 000 |
| 00721902379703 | K021791 | 000 |
| 00721902379659 | K021791 | 000 |
| 00721902379628 | K021791 | 000 |
| 00721902379604 | K021791 | 000 |
| 00721902379598 | K021791 | 000 |
| 00721902379581 | K021791 | 000 |
| 00721902379550 | K021791 | 000 |
| 00721902379536 | K021791 | 000 |
| 00721902379512 | K021791 | 000 |
| 00721902379505 | K021791 | 000 |
| 00721902379444 | K021791 | 000 |
| 00721902379901 | K021791 | 000 |
| 00721902379949 | K021791 | 000 |
| 00721902842733 | K021791 | 000 |
| 00721902666988 | K021791 | 000 |
| 00721902666971 | K021791 | 000 |
| 00721902391286 | K021791 | 000 |
| 00721902391279 | K021791 | 000 |
| 00721902391255 | K021791 | 000 |
| 00721902391248 | K021791 | 000 |
| 00721902380181 | K021791 | 000 |
| 00721902380167 | K021791 | 000 |
| 00721902380150 | K021791 | 000 |
| 00721902380136 | K021791 | 000 |
| 00721902380112 | K021791 | 000 |
| 00721902380105 | K021791 | 000 |
| 00721902380082 | K021791 | 000 |
| 00721902380075 | K021791 | 000 |
| 00721902380013 | K021791 | 000 |
| 00721902379970 | K021791 | 000 |
| 00721902379420 | K021791 | 000 |