NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate— 510(k) K192162

Name: FDA 510(k) clearance K192162
Creator: U.S. Food and Drug Administration
Published: 2020-03-13

Substantially Equivalent

Neurovention, LLC

FDA 510(k) clearance K192162 for NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate, Substantially Equivalent on 2020-03-13. Applicant: Neurovention, LLC. Device class: 2.

Clearance details

Applicant: Neurovention, LLC
Product code: Code GXR
Device class: Class 2
Regulation: 21 CFR 882.5250
Advisory panel: Neurology
Date received: 2019-08-09
Decision date: 2020-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daytona Beach, FL, US

Download summary PDF View on FDA.gov ↗

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