FDA 510(k)

Implante Femoral AFX com Inserção

Número K: K192428 · 2019-10-05

Data da decisão2019-10-05

Código do produtoMBI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

AFX Femoral Implant with Inserter is the device name listed in this FDA 510(k) record. The listed applicant is Cayenne Medical. It received FDA 510(k) clearance on 2019-10-05 under 510(k) number K192428. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AFX Femoral Implant with Inserter?

AFX Femoral Implant with Inserter is a medical device that received FDA 510(k) clearance on 2019-10-05. The listed applicant is Cayenne Medical. The 510(k) number is K192428.

When did AFX Femoral Implant with Inserter receive FDA 510(k) clearance?

AFX Femoral Implant with Inserter received FDA 510(k) clearance on 2019-10-05, under 510(k) number K192428.

Who is the listed applicant for AFX Femoral Implant with Inserter?

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

What is the FDA product code for AFX Femoral Implant with Inserter?

The FDA product code for AFX Femoral Implant with Inserter is MBI.

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Fonte oficial

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