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 Verte-stack Spinal System.

Pre-market Notification Details

Device IDK062073
510k NumberK062073
Device Name:VERTE-STACK SPINAL SYSTEM
ClassificationSpinal Vertebral Body Replacement Device
Applicant MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
ContactLee Grant
CorrespondentLee Grant
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 Received2006-07-21
Decision Date2006-08-14
Summary:summary

NIH GUDID Devices

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