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 | K052931 |
| 510k Number | K052931 |
| 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 | 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 | 2005-10-19 |
| Decision Date | 2005-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885074347752 | K052931 | 000 |
| 00885074347608 | K052931 | 000 |
| 00885074347592 | K052931 | 000 |
| 00885074347578 | K052931 | 000 |
| 00885074347561 | K052931 | 000 |
| 00885074347554 | K052931 | 000 |
| 00885074347547 | K052931 | 000 |
| 00885074347530 | K052931 | 000 |
| 00885074347523 | K052931 | 000 |
| 00885074347516 | K052931 | 000 |
| 00885074347509 | K052931 | 000 |
| 00885074347493 | K052931 | 000 |
| 00885074347615 | K052931 | 000 |
| 00885074347622 | K052931 | 000 |
| 00885074347639 | K052931 | 000 |
| 00885074347745 | K052931 | 000 |
| 00885074347738 | K052931 | 000 |
| 00885074347721 | K052931 | 000 |
| 00885074347714 | K052931 | 000 |
| 00885074347707 | K052931 | 000 |
| 00885074347691 | K052931 | 000 |
| 00885074347684 | K052931 | 000 |
| 00885074347677 | K052931 | 000 |
| 00885074347660 | K052931 | 000 |
| 00885074347653 | K052931 | 000 |
| 00885074347646 | K052931 | 000 |
| 00885074347486 | K052931 | 000 |