PEEK PREVAIL CERVICAL INTERBODY DEVICE

Intervertebral Fusion Device With Integrated Fixation, Cervical

MEDTRONIC SOFAMOR DANEK

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

Pre-market Notification Details

Device IDK113252
510k NumberK113252
Device Name:PEEK PREVAIL CERVICAL INTERBODY DEVICE
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
ContactKristi Frisch
CorrespondentKristi Frisch
MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis,  TN  38132
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-03
Decision Date2012-01-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994853264 K113252 000
00613994753922 K113252 000

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