FDA 510(k)

Precision Casting Solutions Total Hip System

Número K: K192450 · 2019-12-17

RequerentePrecision Casting Solution, LLC

Data da decisão2019-12-17

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Precision Casting Solutions Total Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Precision Casting Solution, LLC. It received FDA 510(k) clearance on 2019-12-17 under 510(k) number K192450. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Precision Casting Solutions Total Hip System?

Precision Casting Solutions Total Hip System is a medical device that received FDA 510(k) clearance on 2019-12-17. The listed applicant is Precision Casting Solution, LLC. The 510(k) number is K192450.

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

Precision Casting Solutions Total Hip System received FDA 510(k) clearance on 2019-12-17, under 510(k) number K192450.

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

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

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

The FDA product code for Precision Casting Solutions Total Hip System is LPH.

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Fonte oficial

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