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FDA 510(k)

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

K-Number: K192162 · 2020-03-13

ApplicantNeurovention, LLC
Decision Date2020-03-13
Product CodeGXR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate is a medical device manufactured by Neurovention, LLC. It received FDA 510(k) clearance on 2020-03-13 under approval number K192162. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate?

NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate is a medical device that received FDA 510(k) clearance on 2020-03-13. It is manufactured by Neurovention, LLC. The 510(k) number is K192162.

When was NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate approved by the FDA?

NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate received FDA 510(k) clearance on 2020-03-13, under approval number K192162.

What company makes NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate?

NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate is manufactured by Neurovention, LLC.

What is the FDA product code for NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate?

The FDA product code for NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate is GXR.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT07608380 Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures ENROLLING_BY_INVITATION NCT06253858 Ultrasound (US) Guided External Ventricular Catheter Placement RECRUITING NCT04115033 Randomized Controlled Trial of CES for Fibromyalgia COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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