FDA 510(k)

EVOS Small Fragment Plating System

Número K: K162078 · 2016-11-18

Data da decisão2016-11-18

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

EVOS Small Fragment Plating System 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 2016-11-18 under 510(k) number K162078. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EVOS Small Fragment Plating System?

EVOS Small Fragment Plating System is a medical device that received FDA 510(k) clearance on 2016-11-18. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K162078.

When did EVOS Small Fragment Plating System receive FDA 510(k) clearance?

EVOS Small Fragment Plating System received FDA 510(k) clearance on 2016-11-18, under 510(k) number K162078.

Who is the listed applicant for EVOS Small Fragment Plating System?

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 EVOS Small Fragment Plating System?

The FDA product code for EVOS Small Fragment Plating System is HRS.

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