FDA 510(k)

U2 Total Knee System, XPE Tibial Insert, PS PLUS

Número K: K210961 · 2021-04-21

Data da decisão2021-04-21

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam United Orthopedic Corporation como candidato(a)

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.K262130ATTUNE Sistema de Quadril de RevisãoDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

Fonte oficial

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