FDA 510(k)

Minimally Invasive Bunion Plating System

Número K: K172178 · 2017-11-16

Data da decisão2017-11-16

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Minimally Invasive Bunion Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Trilliant Surgical, Ltd.. It received FDA 510(k) clearance on 2017-11-16 under 510(k) number K172178. 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 Minimally Invasive Bunion Plating System?

Minimally Invasive Bunion Plating System is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is Trilliant Surgical, Ltd.. The 510(k) number is K172178.

When did Minimally Invasive Bunion Plating System receive FDA 510(k) clearance?

Minimally Invasive Bunion Plating System received FDA 510(k) clearance on 2017-11-16, under 510(k) number K172178.

Who is the listed applicant for Minimally Invasive Bunion Plating System?

The FDA 510(k) record lists Trilliant Surgical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Minimally Invasive Bunion Plating System?

The FDA product code for Minimally Invasive Bunion Plating System is HRS.

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Dispositivos Relacionados (Código: HRS)

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Fonte oficial

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