FDA 510(k)

iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System

Número K: K230846 · 2023-07-17

Data da decisão2023-07-17

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System is the device name listed in this FDA 510(k) record. The listed applicant is Conformis, Inc.. It received FDA 510(k) clearance on 2023-07-17 under 510(k) number K230846. 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 iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System?

iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System is a medical device that received FDA 510(k) clearance on 2023-07-17. The listed applicant is Conformis, Inc.. The 510(k) number is K230846.

When did iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System receive FDA 510(k) clearance?

iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System received FDA 510(k) clearance on 2023-07-17, under 510(k) number K230846.

Who is the listed applicant for iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System?

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

What is the FDA product code for iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System?

The FDA product code for iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System is JWH.

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Outros registros que listam Conformis, Inc. como candidato(a)

K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS K231178Sistema de Quadril ACTERA™K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert K221104Actera® sistema pélvico

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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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