FDA 510(k)

Revolution Spinal Fixation System

Número K: K160216 · 2016-04-22

RequerenteIntelligent Implant Systems, LLC

Data da decisão2016-04-22

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Revolution Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Intelligent Implant Systems, LLC. It received FDA 510(k) clearance on 2016-04-22 under 510(k) number K160216. 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 Revolution Spinal Fixation System?

Revolution Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2016-04-22. The listed applicant is Intelligent Implant Systems, LLC. The 510(k) number is K160216.

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

Revolution Spinal Fixation System received FDA 510(k) clearance on 2016-04-22, under 510(k) number K160216.

Who is the listed applicant for Revolution Spinal Fixation System?

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

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

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

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Fonte oficial

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