FDA 510(k)

SuperCable® Iso-Elastic™ Cerclage System

Número K: K181749 · 2018-08-01

Data da decisão2018-08-01

Código do produtoJDQ

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

SuperCable® Iso-Elastic™ Cerclage System is the device name listed in this FDA 510(k) record. The listed applicant is Kinamed, Incorporated. It received FDA 510(k) clearance on 2018-08-01 under 510(k) number K181749. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SuperCable® Iso-Elastic™ Cerclage System?

SuperCable® Iso-Elastic™ Cerclage System is a medical device that received FDA 510(k) clearance on 2018-08-01. The listed applicant is Kinamed, Incorporated. The 510(k) number is K181749.

When did SuperCable® Iso-Elastic™ Cerclage System receive FDA 510(k) clearance?

SuperCable® Iso-Elastic™ Cerclage System received FDA 510(k) clearance on 2018-08-01, under 510(k) number K181749.

Who is the listed applicant for SuperCable® Iso-Elastic™ Cerclage System?

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

What is the FDA product code for SuperCable® Iso-Elastic™ Cerclage System?

The FDA product code for SuperCable® Iso-Elastic™ Cerclage System is JDQ.

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