FDA 510(k)

BKS Revision Sleeves System

Número K: K181569 · 2018-10-12

Data da decisão2018-10-12

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

BKS Revision Sleeves System is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corporation. It received FDA 510(k) clearance on 2018-10-12 under 510(k) number K181569. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BKS Revision Sleeves System?

BKS Revision Sleeves System is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is Ortho Development Corporation. The 510(k) number is K181569.

When did BKS Revision Sleeves System receive FDA 510(k) clearance?

BKS Revision Sleeves System received FDA 510(k) clearance on 2018-10-12, under 510(k) number K181569.

Who is the listed applicant for BKS Revision Sleeves System?

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

What is the FDA product code for BKS Revision Sleeves System?

The FDA product code for BKS Revision Sleeves System is JWH.

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Fonte oficial

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