FDA 510(k)

Longeviti ClearFit™ OTS Cranial Implants

Número K: K212058 · 2021-09-08

RequerenteLongeviti Neuro Solutions, LLC

Data da decisão2021-09-08

Código do produtoGXN

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Longeviti ClearFit™ OTS Cranial Implants 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 2021-09-08 under 510(k) number K212058. 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 Implants?

Longeviti ClearFit™ OTS Cranial Implants is a medical device that received FDA 510(k) clearance on 2021-09-08. The listed applicant is Longeviti Neuro Solutions, LLC. The 510(k) number is K212058.

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

Longeviti ClearFit™ OTS Cranial Implants received FDA 510(k) clearance on 2021-09-08, under 510(k) number K212058.

Who is the listed applicant for Longeviti ClearFit™ OTS Cranial Implants?

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 Implants?

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

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

K231920Longeviti ClearFit OTS Cranial Implant K211514Longeviti PorousFit implant K210616Longeviti PMMA Static Cranial Implant K203349Longeviti ClearFit Cranial Implant K202901Longeviti ClearFit Cranial Implant K191210Longeviti ClearFit Cranial Implant

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Dispositivos Relacionados (Código: GXN)

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Fonte oficial

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