VERTEX Reconstruction System

Posterior Cervical Screw 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 Vertex Reconstruction System.

Pre-market Notification Details

Device IDK143471
510k NumberK143471
Device Name:VERTEX Reconstruction System
ClassificationPosterior Cervical Screw 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 CodeNKG  
CFR Regulation Number888.3075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-05
Decision Date2015-02-06
Summary:summary

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