NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate

Cover, Burr Hole

NeuroVention LLC

The following data is part of a premarket notification filed by Neurovention Llc with the FDA for Neurovention Cranial Fixation System, Nucrani Plates, Ktc Burr Hole Cover, Dc Plate.

Pre-market Notification Details

Device IDK192162
510k NumberK192162
Device Name:NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate
ClassificationCover, Burr Hole
Applicant NeuroVention LLC 645 S. Beach St. Daytona Beach,  FL  32114
ContactRohit Khanna
CorrespondentRohit Khanna
NeuroVention LLC 645 S. Beach St. Daytona Beach,  FL  32114
Product CodeGXR  
Subsequent Product CodeGWO
Subsequent Product CodeHBW
CFR Regulation Number882.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
510k Review PanelNeurology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-09
Decision Date2020-03-13

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