ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST

Intervertebral Fusion Device With Bone Graft, Lumbar

MEDTRONIC SOFAMOR DANEK, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Anatomic Peek Cervical Fusion System Cornerstone Psr Cervical Fusion System Peek Prevail Cervical Interbody Device Capst.

Pre-market Notification Details

Device IDK122037
510k NumberK122037
Device Name:ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
ContactBecky Ronner
CorrespondentBecky Ronner
MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeMAX  
Subsequent Product CodeODP
Subsequent Product CodeOVD
Subsequent Product CodeOVE
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-11
Decision Date2013-03-22
Summary:summary

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