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 IDK040536
510k NumberK040536
Device Name:MODIFICATION TO VERTE-STACK SPINAL SYSTEM
ClassificationSpinal Vertebral Body Replacement Device
Applicant MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
ContactRichard Treharne
CorrespondentRichard 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 Received2004-03-02
Decision Date2004-05-05
Summary:summary

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