FDA 510(k)

EVOLUTION® Tibial Cones

N.º K: K233507 · 2024-01-18

Fecha de decisión2024-01-18

Código de productoMBH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

EVOLUTION® Tibial Cones 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 2024-01-18 under 510(k) number K233507. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the EVOLUTION® Tibial Cones?

EVOLUTION® Tibial Cones is a medical device that received FDA 510(k) clearance on 2024-01-18. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K233507.

When did EVOLUTION® Tibial Cones receive FDA 510(k) clearance?

EVOLUTION® Tibial Cones received FDA 510(k) clearance on 2024-01-18, under 510(k) number K233507.

Who is the listed applicant for EVOLUTION® Tibial Cones?

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 EVOLUTION® Tibial Cones?

The FDA product code for EVOLUTION® Tibial Cones is MBH.

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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 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 K231947EVOLUTION® Cement Keel

Ver todos los 28 dispositivos →

Dispositivos relacionados (Código: MBH)

K261275Unity Total Knee System, Unity Knee Cementless CR FemurCorin, Ltd.K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.

Fuente oficial

Ver en la base de datos de la FDA →

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