FDA 510(k)

Stem Extension Line (U2 Total Knee System—PSA Type)

N.º K: K252725 · 2025-09-25

SolicitanteUnited Orthopedic Corporation

Fecha de decisión2025-09-25

Código de productoJWH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Stem Extension Line (U2 Total Knee System—PSA Type) 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 2025-09-25 under 510(k) number K252725. 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 Stem Extension Line (U2 Total Knee System—PSA Type)?

Stem Extension Line (U2 Total Knee System—PSA Type) is a medical device that received FDA 510(k) clearance on 2025-09-25. The listed applicant is United Orthopedic Corporation. The 510(k) number is K252725.

When did Stem Extension Line (U2 Total Knee System—PSA Type) receive FDA 510(k) clearance?

Stem Extension Line (U2 Total Knee System—PSA Type) received FDA 510(k) clearance on 2025-09-25, under 510(k) number K252725.

Who is the listed applicant for Stem Extension Line (U2 Total Knee System—PSA Type)?

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 Stem Extension Line (U2 Total Knee System—PSA Type)?

The FDA product code for Stem Extension Line (U2 Total Knee System—PSA Type) is JWH.

Ensayos clínicos relacionados

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Otros registros que enlistan a United Orthopedic Corporation como solicitante

K253948Momentum Acetabular Cup System 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 K243024Cellbrick Knee Spacer

Ver todos los 27 dispositivos →

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 →

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