FDA 510(k)

iNSitu Total Hip System

Número K: K191936 · 2019-08-20

Data da decisão2019-08-20

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

iNSitu Total Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Thecken Companies, LLC. It received FDA 510(k) clearance on 2019-08-20 under 510(k) number K191936. 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 iNSitu Total Hip System?

iNSitu Total Hip System is a medical device that received FDA 510(k) clearance on 2019-08-20. The listed applicant is Thecken Companies, LLC. The 510(k) number is K191936.

When did iNSitu Total Hip System receive FDA 510(k) clearance?

iNSitu Total Hip System received FDA 510(k) clearance on 2019-08-20, under 510(k) number K191936.

Who is the listed applicant for iNSitu Total Hip System?

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

What is the FDA product code for iNSitu Total Hip System?

The FDA product code for iNSitu Total Hip System is LPH.

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Fonte oficial

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