FDA 510(k)

DJO Acetabular System

N.º K: K190057 · 2019-06-07

Fecha de decisión2019-06-07

Código de productoLPH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

DJO Acetabular System is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical L.P.. It received FDA 510(k) clearance on 2019-06-07 under 510(k) number K190057. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the DJO Acetabular System?

DJO Acetabular System is a medical device that received FDA 510(k) clearance on 2019-06-07. The listed applicant is Encore Medical L.P.. The 510(k) number is K190057.

When did DJO Acetabular System receive FDA 510(k) clearance?

DJO Acetabular System received FDA 510(k) clearance on 2019-06-07, under 510(k) number K190057.

Who is the listed applicant for DJO Acetabular System?

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

What is the FDA product code for DJO Acetabular System?

The FDA product code for DJO Acetabular System is LPH.

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Otros registros que enlistan a Encore Medical L.P. como solicitante

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Dispositivos relacionados (Código: LPH)

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Fuente oficial

Ver en la base de datos de la FDA →

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