MODIFICATION TO VERTE-STACK SPINAL SYSTEM

Spinal Vertebral Body Replacement Device

MEDTRONIC SOFAMOR DANEK

The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Modification To Verte-stack Spinal System.

Pre-market Notification Details

Device IDK043561
510k NumberK043561
Device Name:MODIFICATION TO VERTE-STACK SPINAL SYSTEM
ClassificationSpinal Vertebral Body Replacement Device
Applicant MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
ContactRichard A Treharne
CorrespondentRichard A Treharne
MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-12-27
Decision Date2004-12-29
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.