The following data is part of a premarket notification filed by Medtronic Spinal And Biologics Div with the FDA for Modification To Verte-stack Spinal System.
| Device ID | K062133 |
| 510k Number | K062133 |
| Device Name: | MODIFICATION TO VERTE-STACK SPINAL SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | MEDTRONIC SPINAL AND BIOLOGICS DIV 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Lee Grant |
| Correspondent | Lee Grant MEDTRONIC SPINAL AND BIOLOGICS DIV 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 | 2006-07-26 |
| Decision Date | 2006-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885074549736 | K062133 | 000 |
| 00613994236517 | K062133 | 000 |