FDA 510(k)

REDAPT Anteverted Cemented Liner

Número K: K160923 · 2016-11-17

Data da decisão2016-11-17

Código do produtoJDI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

REDAPT Anteverted Cemented Liner is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K160923. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the REDAPT Anteverted Cemented Liner?

REDAPT Anteverted Cemented Liner is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K160923.

When did REDAPT Anteverted Cemented Liner receive FDA 510(k) clearance?

REDAPT Anteverted Cemented Liner received FDA 510(k) clearance on 2016-11-17, under 510(k) number K160923.

Who is the listed applicant for REDAPT Anteverted Cemented Liner?

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

What is the FDA product code for REDAPT Anteverted Cemented Liner?

The FDA product code for REDAPT Anteverted Cemented Liner is JDI.

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