DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM

Intervertebral Fusion Device With Bone Graft, Lumbar

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-l Anterior/oblique Lumbar Fusion System.

Pre-market Notification Details

Device IDK162212
510k NumberK162212
Device Name:DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
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 CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-08
Decision Date2017-05-19
Summary:summary

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