FDA 510(k)

RIGEL 3DR Anterior Cervical Interbody Fusion System

Número K: K200685 · 2020-06-11

Data da decisão2020-06-11

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

RIGEL 3DR Anterior Cervical Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is MiRus, LLC. It received FDA 510(k) clearance on 2020-06-11 under 510(k) number K200685. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the RIGEL 3DR Anterior Cervical Interbody Fusion System?

RIGEL 3DR Anterior Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2020-06-11. The listed applicant is MiRus, LLC. The 510(k) number is K200685.

When did RIGEL 3DR Anterior Cervical Interbody Fusion System receive FDA 510(k) clearance?

RIGEL 3DR Anterior Cervical Interbody Fusion System received FDA 510(k) clearance on 2020-06-11, under 510(k) number K200685.

Who is the listed applicant for RIGEL 3DR Anterior Cervical Interbody Fusion System?

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

What is the FDA product code for RIGEL 3DR Anterior Cervical Interbody Fusion System?

The FDA product code for RIGEL 3DR Anterior Cervical Interbody Fusion System is ODP.

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Outros registros que listam MiRus, LLC como candidato(a)

K253444EUROPA™ Posterior Cervical Fusion Navigated Instruments K252733Sistema de Osteotomia Expansível ATLAS™K242516EUROPA™ Posterior Cervical Fusion System K241175MiRus MoRe Lumbar Plating System K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System K232481RIGEL™ 3DR Anterior Cervical Corpectomy System

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Dispositivos Relacionados (Código: ODP)

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Fonte oficial

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