FDA 510(k)

Rexious Spinal Fixation System

Número K: K173131 · 2017-12-08

Data da decisão2017-12-08

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Rexious Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Huvexel Co. , Ltd.. It received FDA 510(k) clearance on 2017-12-08 under 510(k) number K173131. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Rexious Spinal Fixation System?

Rexious Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2017-12-08. The listed applicant is Huvexel Co. , Ltd.. The 510(k) number is K173131.

When did Rexious Spinal Fixation System receive FDA 510(k) clearance?

Rexious Spinal Fixation System received FDA 510(k) clearance on 2017-12-08, under 510(k) number K173131.

Who is the listed applicant for Rexious Spinal Fixation System?

The FDA 510(k) record lists Huvexel Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rexious Spinal Fixation System?

The FDA product code for Rexious Spinal Fixation System is NKB.

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Fonte oficial

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