FDA 510(k)

MOBIO Total Knee System

Número K: K210483 · 2021-04-21

Data da decisão2021-04-21

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

MOBIO Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is B-One Ortho, Corp.. It received FDA 510(k) clearance on 2021-04-21 under 510(k) number K210483. 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 MOBIO Total Knee System?

MOBIO Total Knee System is a medical device that received FDA 510(k) clearance on 2021-04-21. The listed applicant is B-One Ortho, Corp.. The 510(k) number is K210483.

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

MOBIO Total Knee System received FDA 510(k) clearance on 2021-04-21, under 510(k) number K210483.

Who is the listed applicant for MOBIO Total Knee System?

The FDA 510(k) record lists B-One Ortho, Corp. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Outros registros que listam B-One Ortho, Corp. como candidato(a)

K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions K253357b-ONE® Bipolar Head K240528b-ONE® Total Hip System K222431b-ONER MOBIO Total Knee System K213673b-ONE MOBIO Total Knee System K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System

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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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