FDA 510(k)

Dispositivo de Fixação Ajustável

Número K: K153186 · 2016-01-28

Data da decisão2016-01-28

Código do produtoMBI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Adjustable Fixation Device is the device name listed in this FDA 510(k) record. The listed applicant is Arthrocare Corp.. It received FDA 510(k) clearance on 2016-01-28 under 510(k) number K153186. 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 Adjustable Fixation Device?

Adjustable Fixation Device is a medical device that received FDA 510(k) clearance on 2016-01-28. The listed applicant is Arthrocare Corp.. The 510(k) number is K153186.

When did Adjustable Fixation Device receive FDA 510(k) clearance?

Adjustable Fixation Device received FDA 510(k) clearance on 2016-01-28, under 510(k) number K153186.

Who is the listed applicant for Adjustable Fixation Device?

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

What is the FDA product code for Adjustable Fixation Device?

The FDA product code for Adjustable Fixation Device is MBI.

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