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FDA 510(k)

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

Número K: K192162 · 2020-03-13

RequerenteNeurovention, LLC
Data da decisão2020-03-13
Código do produtoGXR
Comité consultivoNE
DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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