FDA 510(k)

iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System

N.º K: K230846 · 2023-07-17

Fecha de decisión2023-07-17

Código de productoJWH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Conformis, Inc. como solicitante

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 K231178ACTERA™ hip system K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert K221104Sistema de Cadera Actera™

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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.K262130Sistema de Rodilla Revision ATTUNEDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.