FDA 510(k)

MultiFIX S Ultra Knotless Fixation System

Número K: K153669 · 2016-01-19

Data da decisão2016-01-19

Código do produtoMBI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

MultiFIX S Ultra Knotless Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Arthocare Corporation. It received FDA 510(k) clearance on 2016-01-19 under 510(k) number K153669. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MultiFIX S Ultra Knotless Fixation System?

MultiFIX S Ultra Knotless Fixation System is a medical device that received FDA 510(k) clearance on 2016-01-19. The listed applicant is Arthocare Corporation. The 510(k) number is K153669.

When did MultiFIX S Ultra Knotless Fixation System receive FDA 510(k) clearance?

MultiFIX S Ultra Knotless Fixation System received FDA 510(k) clearance on 2016-01-19, under 510(k) number K153669.

Who is the listed applicant for MultiFIX S Ultra Knotless Fixation System?

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

What is the FDA product code for MultiFIX S Ultra Knotless Fixation System?

The FDA product code for MultiFIX S Ultra Knotless Fixation System is MBI.

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