FDA 510(k)

Sistema de Placagem de Fusão de Tálus

Número K: K173121 · 2017-11-28

Data da decisão2017-11-28

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ankle Fusion Plating System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones Sas. It received FDA 510(k) clearance on 2017-11-28 under 510(k) number K173121. 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 Ankle Fusion Plating System?

Ankle Fusion Plating System is a medical device that received FDA 510(k) clearance on 2017-11-28. The listed applicant is In2bones Sas. The 510(k) number is K173121.

When did Ankle Fusion Plating System receive FDA 510(k) clearance?

Ankle Fusion Plating System received FDA 510(k) clearance on 2017-11-28, under 510(k) number K173121.

Who is the listed applicant for Ankle Fusion Plating System?

The FDA 510(k) record lists In2bones Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ankle Fusion Plating System?

The FDA product code for Ankle Fusion Plating System is HRS.

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