MODIFICATION TO VERTE-STACK SPINAL SYSTEM

Spinal Vertebral Body Replacement Device

MEDTRONIC SPINAL AND BIOLOGICS DIV

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.

Pre-market Notification Details

Device IDK062133
510k NumberK062133
Device Name:MODIFICATION TO VERTE-STACK SPINAL SYSTEM
ClassificationSpinal Vertebral Body Replacement Device
Applicant MEDTRONIC SPINAL AND BIOLOGICS DIV 1800 PYRAMID PLACE Memphis,  TN  38132
ContactLee Grant
CorrespondentLee Grant
MEDTRONIC SPINAL AND BIOLOGICS DIV 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeMQP  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-26
Decision Date2006-09-26
Summary:summary

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