FDA 510(k)

EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)

N.º K: K251241 · 2025-07-02

Fecha de decisión2025-07-02

Código de productoJWH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical L.P.. It received FDA 510(k) clearance on 2025-07-02 under 510(k) number K251241. 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 EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)?

EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Encore Medical L.P.. The 510(k) number is K251241.

When did EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) receive FDA 510(k) clearance?

EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) received FDA 510(k) clearance on 2025-07-02, under 510(k) number K251241.

Who is the listed applicant for EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)?

The FDA 510(k) record lists Encore Medical L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)?

The FDA product code for EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) is JWH.

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Otros registros que enlistan a Encore Medical L.P. como solicitante

K252567Globo Glenosphere ADLC Invertido AltiVate®K252974EMPOWR Knee K251833EMPOWR Acetabular® Liner Extension K252141Glenoid Invertido AltiVate®K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)K251184Sistema de Hombro Invertido AltiVate; Sistema de Hombro RSP; Sistema de Hombro SMR; Sistema Humeral PRIMA; Sistema Glenoid PRIMA

Ver todos los 31 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.