The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Verte-stack Spinal System.
Device ID | K062427 |
510k Number | K062427 |
Device Name: | VERTE-STACK SPINAL SYSTEM |
Classification | Spinal Vertebral Body Replacement Device |
Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
Contact | Edward Chin |
Correspondent | Edward Chin 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 | 2006-08-18 |
Decision Date | 2006-09-12 |
Summary: | summary |