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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 the device name listed in this FDA 510(k) record. The listed applicant is Neurovention, LLC. It received FDA 510(k) clearance on 2020-03-13 under 510(k) 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. The listed applicant is Neurovention, LLC. The 510(k) number is K192162.

When did NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate receive FDA 510(k) clearance?

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

Who is the listed applicant for NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate?

The FDA 510(k) record lists Neurovention, LLC as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06899711External Post-Operative Skull Prosthesis to Prevent Sunken Flap Syndrome in Craniectomy PatientsRECRUITINGNCT07375030Evaluation of Patient-specific Surgical Stents and Plates for Guided Reduction And Fixation of Mandibular Angle FracturesCOMPLETEDNCT07520227Comparative Evaluation of 3D-printed (PEEK) Plates Versus Titanium 3D Plate for Fracture Fixation at the Mandibular AngleCOMPLETEDNCT07608380Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex FracturesENROLLING_BY_INVITATIONNCT07736430Evaluation of Pin Buckle Bone Plates for Management of Anterior Mandibular FracturesCOMPLETED

Related Devices (Code: GXR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemNeos Surgery S.LK221606Absorbable Cranial Flap Fixation SystemChendu Medart Medical Scientific Co., Ltd.K192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd.K181539OSSDSIGN CranioplugOssdsign ABK181382GuardianTM Burr Hole Cover SystemSt Jude Medical

Official Source

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

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