FDA 510(k)

U2 Total Knee System, XPE Tibial Insert, PS PLUS

N.º K: K210961 · 2021-04-21

SolicitanteUnited Orthopedic Corporation

Fecha de decisión2021-04-21

Código de productoJWH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

U2 Total Knee System, XPE Tibial Insert, PS PLUS is the device name listed in this FDA 510(k) record. The listed applicant is United Orthopedic Corporation. It received FDA 510(k) clearance on 2021-04-21 under 510(k) number K210961. 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 U2 Total Knee System, XPE Tibial Insert, PS PLUS?

U2 Total Knee System, XPE Tibial Insert, PS PLUS is a medical device that received FDA 510(k) clearance on 2021-04-21. The listed applicant is United Orthopedic Corporation. The 510(k) number is K210961.

When did U2 Total Knee System, XPE Tibial Insert, PS PLUS receive FDA 510(k) clearance?

U2 Total Knee System, XPE Tibial Insert, PS PLUS received FDA 510(k) clearance on 2021-04-21, under 510(k) number K210961.

Who is the listed applicant for U2 Total Knee System, XPE Tibial Insert, PS PLUS?

The FDA 510(k) record lists United Orthopedic Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U2 Total Knee System, XPE Tibial Insert, PS PLUS?

The FDA product code for U2 Total Knee System, XPE Tibial Insert, PS PLUS is JWH.

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Otros registros que enlistan a United Orthopedic Corporation como solicitante

K253948Momentum Acetabular Cup System K252725Stem Extension Line (U2 Total Knee System—PSA Type)K252303Stem Extension Line (USTAR II System)K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella K242315Resolve Modular Revision Hip Stem K243466Conformity Stem Extension Line, #0

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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

Ver en la base de datos de la FDA →

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