FDA 510(k)

OrthoPediatrics PediFoot Deformity Corrections System

Número K: K190992 · 2019-08-06

Data da decisão2019-08-06

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

OrthoPediatrics PediFoot Deformity Corrections System is the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2019-08-06 under 510(k) number K190992. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OrthoPediatrics PediFoot Deformity Corrections System?

OrthoPediatrics PediFoot Deformity Corrections System is a medical device that received FDA 510(k) clearance on 2019-08-06. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K190992.

When did OrthoPediatrics PediFoot Deformity Corrections System receive FDA 510(k) clearance?

OrthoPediatrics PediFoot Deformity Corrections System received FDA 510(k) clearance on 2019-08-06, under 510(k) number K190992.

Who is the listed applicant for OrthoPediatrics PediFoot Deformity Corrections System?

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

What is the FDA product code for OrthoPediatrics PediFoot Deformity Corrections System?

The FDA product code for OrthoPediatrics PediFoot Deformity Corrections System is HRS.

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Fonte oficial

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