CD HORIZON Growth Rod Conversion Set

Growing Rod System

MEDTRONIC SOFAMOR DANEK USA, INCORPORATED

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Incorporated with the FDA for Cd Horizon Growth Rod Conversion Set.

Pre-market Notification Details

Device IDK150200
510k NumberK150200
Device Name:CD HORIZON Growth Rod Conversion Set
ClassificationGrowing Rod System
Applicant MEDTRONIC SOFAMOR DANEK USA, INCORPORATED 1800 PYRAMID PLACE Memphis,  TN  38132 -3576
ContactLee Grant
CorrespondentLee Grant
MEDTRONIC SOFAMOR DANEK USA, INCORPORATED 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodePGM  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-29
Decision Date2015-02-25
Summary:summary

NIH GUDID Devices

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