FDA 510(k)

Sistema Anterior AdvantageRib

Número K: K182179 · 2018-11-16

Data da decisão2018-11-16

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

AdvantageRib Anterior System is the device name listed in this FDA 510(k) record. The listed applicant is Sig Medical Corp.. It received FDA 510(k) clearance on 2018-11-16 under 510(k) number K182179. 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 AdvantageRib Anterior System?

AdvantageRib Anterior System is a medical device that received FDA 510(k) clearance on 2018-11-16. The listed applicant is Sig Medical Corp.. The 510(k) number is K182179.

When did AdvantageRib Anterior System receive FDA 510(k) clearance?

AdvantageRib Anterior System received FDA 510(k) clearance on 2018-11-16, under 510(k) number K182179.

Who is the listed applicant for AdvantageRib Anterior System?

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

What is the FDA product code for AdvantageRib Anterior System?

The FDA product code for AdvantageRib Anterior System is HRS.

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