SHILLA GROWTH GUIDANCE SYSTEM

Growing Rod System

MEDTRONIC SOFAMOR DANEK USA, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Shilla Growth Guidance System.

Pre-market Notification Details

Device IDK140750
510k NumberK140750
Device Name:SHILLA GROWTH GUIDANCE SYSTEM
ClassificationGrowing Rod System
Applicant MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactLee Grant
CorrespondentLee Grant
MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodePGM  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-25
Decision Date2014-07-17
Summary:summary

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