FDA 510(k)

Prótese de Quadril ACTIS Duofix

Número K: K202472 · 2020-10-21

Data da decisão2020-10-21

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ACTIS Duofix Hip Prosthesis is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2020-10-21 under 510(k) number K202472. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ACTIS Duofix Hip Prosthesis?

ACTIS Duofix Hip Prosthesis is a medical device that received FDA 510(k) clearance on 2020-10-21. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K202472.

When did ACTIS Duofix Hip Prosthesis receive FDA 510(k) clearance?

ACTIS Duofix Hip Prosthesis received FDA 510(k) clearance on 2020-10-21, under 510(k) number K202472.

Who is the listed applicant for ACTIS Duofix Hip Prosthesis?

The FDA 510(k) record lists DePuy Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACTIS Duofix Hip Prosthesis?

The FDA product code for ACTIS Duofix Hip Prosthesis is LPH.

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Outros registros que listam DePuy Orthopaedics, Inc. como candidato(a)

K262130ATTUNE Sistema de Quadril de Revisão K252887DePuy ATTUNE™ Knee System K231503CUPTIMIZE™ Advanced K213839DePuy Corail AMT Hip Prosthesis K210167DELTA XTEND Reverse Shoulder System K203167DePuy Corail AMT Hip Prosthesis

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Fonte oficial

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