FDA 510(k)

EMPOWR Acetabular® Liner Extension

N.º K: K251833 · 2025-11-12

Fecha de decisión2025-11-12

Código de productoLPH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

EMPOWR Acetabular® Liner Extension 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 2025-11-12 under 510(k) number K251833. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the EMPOWR Acetabular® Liner Extension?

EMPOWR Acetabular® Liner Extension is a medical device that received FDA 510(k) clearance on 2025-11-12. The listed applicant is Encore Medical L.P.. The 510(k) number is K251833.

When did EMPOWR Acetabular® Liner Extension receive FDA 510(k) clearance?

EMPOWR Acetabular® Liner Extension received FDA 510(k) clearance on 2025-11-12, under 510(k) number K251833.

Who is the listed applicant for EMPOWR Acetabular® Liner Extension?

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 Acetabular® Liner Extension?

The FDA product code for EMPOWR Acetabular® Liner Extension is LPH.

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

K252567Globo Glenosphere ADLC Invertido AltiVate®K252974EMPOWR Knee K252141Glenoid Invertido AltiVate®K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)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: LPH)

K261453G7® Acetabular SystemZimmer Biomet K253630Mpact 3D Metal FoamMedacta International S.A.K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC K251270Taperloc® Complete Hip StemBiomet, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

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