FDA 510(k)

Destiknee™ Total Knee System

Número K: K172936 · 2017-11-30

Data da decisão2017-11-30

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Destiknee™ Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Meril Healthcare Pvt. , Ltd.. It received FDA 510(k) clearance on 2017-11-30 under 510(k) number K172936. 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 Destiknee™ Total Knee System?

Destiknee™ Total Knee System is a medical device that received FDA 510(k) clearance on 2017-11-30. The listed applicant is Meril Healthcare Pvt. , Ltd.. The 510(k) number is K172936.

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

Destiknee™ Total Knee System received FDA 510(k) clearance on 2017-11-30, under 510(k) number K172936.

Who is the listed applicant for Destiknee™ Total Knee System?

The FDA 510(k) record lists Meril Healthcare Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Destiknee™ Total Knee System?

The FDA product code for Destiknee™ Total Knee System is JWH.

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Outros registros que listam Meril Healthcare Pvt. , Ltd. como candidato(a)

K222436Latitud™ Hip Replacement System K222816Opulent TiNbN Coated Knee K212839Opulent TiNbN Coated Knee K183532Latitud Hip Replacement System K172857Latitud Hip Replacement System K171320Pranchas e Parafusos MBOSS / FIXION Pequenos Fragmentos e Tálus ARMAR / ARTIS, Pranchas e Parafusos do Humero e Olecrano ARMAR / ARTIS, Pranchas e Parafusos Tibiais e de Suporte ARMAR / ARTIS, Pranchas ARMAR / ARTIS 2.4mm e Parafusos MBOSS / FIXION, Prancha de Gancho Clavicular ARMAR / ARTIS e Parafusos MBOSS / FIXION, Prancha Metáfise ARMAR / ARTIS e Parafusos MBOSS / FIXION, Prancha de Tálus ARMAR / ARTIS e Parafusos MBOSS / FIXION

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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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