DIVERGENCE Anterior Cervical Fusion System

Intervertebral Fusion Device With Bone Graft, Cervical

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 Divergence Anterior Cervical Fusion System.

Pre-market Notification Details

Device IDK142450
510k NumberK142450
Device Name:DIVERGENCE Anterior Cervical Fusion System
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis,  TN  38132
ContactShweta Sharma
CorrespondentShweta Sharma
MEDTRONIC SOFAMOR DANEK USA, INC 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-02
Decision Date2014-10-01
Summary:summary

NIH GUDID Devices

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