FDA 510(k)

Piccolo Composite® Plate System

Número K: K182015 · 2018-10-11

Data da decisão2018-10-11

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Piccolo Composite® Plate System is the device name listed in this FDA 510(k) record. The listed applicant is CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2018-10-11 under 510(k) number K182015. 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 Piccolo Composite® Plate System?

Piccolo Composite® Plate System is a medical device that received FDA 510(k) clearance on 2018-10-11. The listed applicant is CarboFix Orthopedics , Ltd.. The 510(k) number is K182015.

When did Piccolo Composite® Plate System receive FDA 510(k) clearance?

Piccolo Composite® Plate System received FDA 510(k) clearance on 2018-10-11, under 510(k) number K182015.

Who is the listed applicant for Piccolo Composite® Plate System?

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

What is the FDA product code for Piccolo Composite® Plate System?

The FDA product code for Piccolo Composite® Plate System is HRS.

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Fonte oficial

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