FDA 510(k)

Styrker OrthoMap Express Knee System

N.º K: K153240 · 2016-07-07

Fecha de decisión2016-07-07

Código de productoOLO

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Styrker OrthoMap Express Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporate. It received FDA 510(k) clearance on 2016-07-07 under 510(k) number K153240. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Styrker OrthoMap Express Knee System?

Styrker OrthoMap Express Knee System is a medical device that received FDA 510(k) clearance on 2016-07-07. The listed applicant is Stryker Corporate. The 510(k) number is K153240.

When did Styrker OrthoMap Express Knee System receive FDA 510(k) clearance?

Styrker OrthoMap Express Knee System received FDA 510(k) clearance on 2016-07-07, under 510(k) number K153240.

Who is the listed applicant for Styrker OrthoMap Express Knee System?

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

What is the FDA product code for Styrker OrthoMap Express Knee System?

The FDA product code for Styrker OrthoMap Express Knee System is OLO.

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Fuente oficial

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