FDA 510(k)

FORTEZZA Spinal Stabilization System

N.º K: K162576 · 2016-11-10

Fecha de decisión2016-11-10

Código de productoNKB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

FORTEZZA Spinal Stabilization System is the device name listed in this FDA 510(k) record. The listed applicant is Osso Surgical. It received FDA 510(k) clearance on 2016-11-10 under 510(k) number K162576. 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 FORTEZZA Spinal Stabilization System?

FORTEZZA Spinal Stabilization System is a medical device that received FDA 510(k) clearance on 2016-11-10. The listed applicant is Osso Surgical. The 510(k) number is K162576.

When did FORTEZZA Spinal Stabilization System receive FDA 510(k) clearance?

FORTEZZA Spinal Stabilization System received FDA 510(k) clearance on 2016-11-10, under 510(k) number K162576.

Who is the listed applicant for FORTEZZA Spinal Stabilization System?

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

What is the FDA product code for FORTEZZA Spinal Stabilization System?

The FDA product code for FORTEZZA Spinal Stabilization System is NKB.

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Fuente oficial

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