FDA 510(k)

Longeviti ClearFit OTS Cranial Implant

Número K: K231920 · 2023-11-09

RequerenteLongeviti Neuro Solutions, LLC

Data da decisão2023-11-09

Código do produtoGXN

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Longeviti ClearFit OTS Cranial Implant is the device name listed in this FDA 510(k) record. The listed applicant is Longeviti Neuro Solutions, LLC. It received FDA 510(k) clearance on 2023-11-09 under 510(k) number K231920. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Longeviti ClearFit OTS Cranial Implant?

Longeviti ClearFit OTS Cranial Implant is a medical device that received FDA 510(k) clearance on 2023-11-09. The listed applicant is Longeviti Neuro Solutions, LLC. The 510(k) number is K231920.

When did Longeviti ClearFit OTS Cranial Implant receive FDA 510(k) clearance?

Longeviti ClearFit OTS Cranial Implant received FDA 510(k) clearance on 2023-11-09, under 510(k) number K231920.

Who is the listed applicant for Longeviti ClearFit OTS Cranial Implant?

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

What is the FDA product code for Longeviti ClearFit OTS Cranial Implant?

The FDA product code for Longeviti ClearFit OTS Cranial Implant is GXN.

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Outros registros que listam Longeviti Neuro Solutions, LLC como candidato(a)

K212058Longeviti ClearFit™ OTS Cranial Implants K211514Longeviti PorousFit implant K210616Longeviti PMMA Static Cranial Implant K203349Longeviti ClearFit Cranial Implant K202901Longeviti ClearFit Cranial Implant K191210Longeviti ClearFit Cranial Implant

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Fonte oficial

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