FDA 510(k)

KeYi Total Knee System

Número K: K230120 · 2024-04-19

RequerenteBeijing Keyi Medical Device Technology Co., Ltd.

Data da decisão2024-04-19

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

KeYi Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Keyi Medical Device Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-04-19 under 510(k) number K230120. 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 KeYi Total Knee System?

KeYi Total Knee System is a medical device that received FDA 510(k) clearance on 2024-04-19. The listed applicant is Beijing Keyi Medical Device Technology Co., Ltd.. The 510(k) number is K230120.

When did KeYi Total Knee System receive FDA 510(k) clearance?

KeYi Total Knee System received FDA 510(k) clearance on 2024-04-19, under 510(k) number K230120.

Who is the listed applicant for KeYi Total Knee System?

The FDA 510(k) record lists Beijing Keyi Medical Device Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KeYi Total Knee System?

The FDA product code for KeYi Total Knee System is JWH.

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Dispositivos Relacionados (Código: JWH)

K262057GMK ExtensionMedacta International SA K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Sistema de Quadril de RevisãoDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

Fonte oficial

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