FDA 510(k)

Ceramic Femoral Head

N.º K: K240452 · 2024-04-12

Fecha de decisión2024-04-12

Código de productoLZO

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Ceramic Femoral Head 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 2024-04-12 under 510(k) number K240452. 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 Ceramic Femoral Head?

Ceramic Femoral Head is a medical device that received FDA 510(k) clearance on 2024-04-12. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K240452.

When did Ceramic Femoral Head receive FDA 510(k) clearance?

Ceramic Femoral Head received FDA 510(k) clearance on 2024-04-12, under 510(k) number K240452.

Who is the listed applicant for Ceramic Femoral Head?

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 Ceramic Femoral Head?

The FDA product code for Ceramic Femoral Head is LZO.

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

K253728EVOLUTION® AM BIOFOAM® Tibial System K250444NEXUS® Hip Stem K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique 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

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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 →

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