FDA 510(k)

Gexfix External Fixation

Número K: K160972 · 2016-12-28

Data da decisão2016-12-28

Código do produtoKTT

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Gexfix External Fixation is the device name listed in this FDA 510(k) record. The listed applicant is Gexfix International Corp.. It received FDA 510(k) clearance on 2016-12-28 under 510(k) number K160972. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Gexfix External Fixation?

Gexfix External Fixation is a medical device that received FDA 510(k) clearance on 2016-12-28. The listed applicant is Gexfix International Corp.. The 510(k) number is K160972.

When did Gexfix External Fixation receive FDA 510(k) clearance?

Gexfix External Fixation received FDA 510(k) clearance on 2016-12-28, under 510(k) number K160972.

Who is the listed applicant for Gexfix External Fixation?

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

What is the FDA product code for Gexfix External Fixation?

The FDA product code for Gexfix External Fixation is KTT.

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Fonte oficial

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