FDA 510(k)

Sistema de Cadera Cementada Alpine

N.º K: K153216 · 2016-02-18

SolicitanteOrtho Development Corporation

Fecha de decisión2016-02-18

Código de productoJDI

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Alpine Cemented Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corporation. It received FDA 510(k) clearance on 2016-02-18 under 510(k) number K153216. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Alpine Cemented Hip System?

Alpine Cemented Hip System is a medical device that received FDA 510(k) clearance on 2016-02-18. The listed applicant is Ortho Development Corporation. The 510(k) number is K153216.

When did Alpine Cemented Hip System receive FDA 510(k) clearance?

Alpine Cemented Hip System received FDA 510(k) clearance on 2016-02-18, under 510(k) number K153216.

Who is the listed applicant for Alpine Cemented Hip System?

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

What is the FDA product code for Alpine Cemented Hip System?

The FDA product code for Alpine Cemented Hip System is JDI.

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Dispositivos relacionados (Código: JDI)

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Fuente oficial

Ver en la base de datos de la FDA →

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