FDA 510(k)

Precision Casting Solutions Total Knee System

N.º K: K190355 · 2019-05-16

SolicitantePrecision Casting Solutions, Inc.

Fecha de decisión2019-05-16

Código de productoJWH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Precision Casting Solutions Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Precision Casting Solutions, Inc.. It received FDA 510(k) clearance on 2019-05-16 under 510(k) number K190355. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Precision Casting Solutions Total Knee System?

Precision Casting Solutions Total Knee System is a medical device that received FDA 510(k) clearance on 2019-05-16. The listed applicant is Precision Casting Solutions, Inc.. The 510(k) number is K190355.

When did Precision Casting Solutions Total Knee System receive FDA 510(k) clearance?

Precision Casting Solutions Total Knee System received FDA 510(k) clearance on 2019-05-16, under 510(k) number K190355.

Who is the listed applicant for Precision Casting Solutions Total Knee System?

The FDA 510(k) record lists Precision Casting Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Precision Casting Solutions Total Knee System?

The FDA product code for Precision Casting Solutions Total Knee System is JWH.

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Dispositivos relacionados (Código: JWH)

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Fuente oficial

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