FDA 510(k)

VERTICALE® Posterior Spinal Fixation System/VERTICALE® System

N.º K: K171421 · 2018-01-10

Fecha de decisión2018-01-10

Código de productoNKB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

VERTICALE® Posterior Spinal Fixation System/VERTICALE® System is the device name listed in this FDA 510(k) record. The listed applicant is Silony Medical GmbH. It received FDA 510(k) clearance on 2018-01-10 under 510(k) number K171421. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the VERTICALE® Posterior Spinal Fixation System/VERTICALE® System?

VERTICALE® Posterior Spinal Fixation System/VERTICALE® System is a medical device that received FDA 510(k) clearance on 2018-01-10. The listed applicant is Silony Medical GmbH. The 510(k) number is K171421.

When did VERTICALE® Posterior Spinal Fixation System/VERTICALE® System receive FDA 510(k) clearance?

VERTICALE® Posterior Spinal Fixation System/VERTICALE® System received FDA 510(k) clearance on 2018-01-10, under 510(k) number K171421.

Who is the listed applicant for VERTICALE® Posterior Spinal Fixation System/VERTICALE® System?

The FDA 510(k) record lists Silony Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERTICALE® Posterior Spinal Fixation System/VERTICALE® System?

The FDA product code for VERTICALE® Posterior Spinal Fixation System/VERTICALE® System is NKB.

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Fuente oficial

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