MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX

Dura Substitute

MEDTRONIC NEUROSURGERY

The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Modification To Durepair Dura Regeneration Matrix.

Pre-market Notification Details

Device IDK063117
510k NumberK063117
Device Name:MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX
ClassificationDura Substitute
Applicant MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta,  CA  93117
ContactJeffery Henderson
CorrespondentJeffery Henderson
MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta,  CA  93117
Product CodeGXQ  
CFR Regulation Number882.5910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-10-12
Decision Date2006-11-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169063907 K063117 000
00643169063891 K063117 000
00643169063884 K063117 000
00643169063877 K063117 000
00643169063860 K063117 000
00643169063853 K063117 000

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