The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Verte-stack Spinal System.
| Device ID | K061938 |
| 510k Number | K061938 |
| Device Name: | VERTE-STACK SPINAL SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Lee Grant |
| Correspondent | Lee Grant MEDTRONIC SOFAMOR DANEK, INC. 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 | 2006-07-10 |
| Decision Date | 2006-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902913143 | K061938 | 000 |
| 00721902913136 | K061938 | 000 |
| 00721902913129 | K061938 | 000 |