FDA 510(k)

MIS Bunion System

Número K: K181872 · 2019-02-19

RequerenteCrossroads Extremity Systems, LLC

Data da decisão2019-02-19

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

MIS Bunion System is the device name listed in this FDA 510(k) record. The listed applicant is Crossroads Extremity Systems, LLC. It received FDA 510(k) clearance on 2019-02-19 under 510(k) number K181872. 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 MIS Bunion System?

MIS Bunion System is a medical device that received FDA 510(k) clearance on 2019-02-19. The listed applicant is Crossroads Extremity Systems, LLC. The 510(k) number is K181872.

When did MIS Bunion System receive FDA 510(k) clearance?

MIS Bunion System received FDA 510(k) clearance on 2019-02-19, under 510(k) number K181872.

Who is the listed applicant for MIS Bunion System?

The FDA 510(k) record lists Crossroads Extremity Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIS Bunion System?

The FDA product code for MIS Bunion System is HRS.

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Fonte oficial

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