FDA 510(k)

DePuy Corail AMT Hip Prosthesis

Número K: K173960 · 2018-09-21

Data da decisão2018-09-21

Código do produtoLZO

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

DePuy Corail AMT Hip Prosthesis is the device name listed in this FDA 510(k) record. The listed applicant is Depuy France S.A.S.. It received FDA 510(k) clearance on 2018-09-21 under 510(k) number K173960. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DePuy Corail AMT Hip Prosthesis?

DePuy Corail AMT Hip Prosthesis is a medical device that received FDA 510(k) clearance on 2018-09-21. The listed applicant is Depuy France S.A.S.. The 510(k) number is K173960.

When did DePuy Corail AMT Hip Prosthesis receive FDA 510(k) clearance?

DePuy Corail AMT Hip Prosthesis received FDA 510(k) clearance on 2018-09-21, under 510(k) number K173960.

Who is the listed applicant for DePuy Corail AMT Hip Prosthesis?

The FDA 510(k) record lists Depuy France S.A.S. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DePuy Corail AMT Hip Prosthesis?

The FDA product code for DePuy Corail AMT Hip Prosthesis is LZO.

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Fonte oficial

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