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 | K041197 |
| 510k Number | K041197 |
| 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 | 2004-05-07 |
| Decision Date | 2004-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994144195 | K041197 | 000 |
| 00613994144171 | K041197 | 000 |
| 00721902807466 | K041197 | 000 |
| 00721902807442 | K041197 | 000 |
| 00885074354330 | K041197 | 000 |