FDA 510(k)

ACCUFUSE Cervical System

N.º K: K181471 · 2018-08-29

SolicitanteAbsolute Advantage Medical, LLC

Fecha de decisión2018-08-29

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

ACCUFUSE Cervical System is the device name listed in this FDA 510(k) record. The listed applicant is Absolute Advantage Medical, LLC. It received FDA 510(k) clearance on 2018-08-29 under 510(k) number K181471. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ACCUFUSE Cervical System?

ACCUFUSE Cervical System is a medical device that received FDA 510(k) clearance on 2018-08-29. The listed applicant is Absolute Advantage Medical, LLC. The 510(k) number is K181471.

When did ACCUFUSE Cervical System receive FDA 510(k) clearance?

ACCUFUSE Cervical System received FDA 510(k) clearance on 2018-08-29, under 510(k) number K181471.

Who is the listed applicant for ACCUFUSE Cervical System?

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

What is the FDA product code for ACCUFUSE Cervical System?

The FDA product code for ACCUFUSE Cervical System is ODP.

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Fuente oficial

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