FDA 510(k)

NEXUS® Hip Stem

N.º K: K250444 · 2025-05-15

Fecha de decisión2025-05-15

Código de productoLZO

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

NEXUS® Hip Stem is the device name listed in this FDA 510(k) record. The listed applicant is Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2025-05-15 under 510(k) number K250444. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the NEXUS® Hip Stem?

NEXUS® Hip Stem is a medical device that received FDA 510(k) clearance on 2025-05-15. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K250444.

When did NEXUS® Hip Stem receive FDA 510(k) clearance?

NEXUS® Hip Stem received FDA 510(k) clearance on 2025-05-15, under 510(k) number K250444.

Who is the listed applicant for NEXUS® Hip Stem?

The FDA 510(k) record lists Microport Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEXUS® Hip Stem?

The FDA product code for NEXUS® Hip Stem is LZO.

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Otros registros que enlistan a Microport Orthopedics, Inc. como solicitante

K253728EVOLUTION® AM BIOFOAM® Tibial System K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique K240452Ceramic Femoral Head K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse K233507EVOLUTION® Tibial Cones K231947EVOLUTION® Cement Keel

Ver todos los 28 dispositivos →

Dispositivos relacionados (Código: LZO)

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG K260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH

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.