CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE

Intervertebral Fusion Device With Bone Graft, Cervical

MEDTRONIC SOFAMOR DANEK

The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Cornerstone Psr Cervical Interbody Fusion Device.

Pre-market Notification Details

Device IDK100214
510k NumberK100214
Device Name:CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
ContactLee Grant
CorrespondentLee Grant
MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-01-25
Decision Date2010-06-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00613994367426 K100214 000
00613994366108 K100214 000
00613994366092 K100214 000
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00613994365934 K100214 000

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