FDA 510(k)

MPO Total Knee Systems MR Labeling

N.º K: K152631 · 2016-03-23

Fecha de decisión2016-03-23

Código de productoHRY

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

MPO Total Knee Systems MR Labeling 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 2016-03-23 under 510(k) number K152631. The device is classified under product code HRY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the MPO Total Knee Systems MR Labeling?

MPO Total Knee Systems MR Labeling is a medical device that received FDA 510(k) clearance on 2016-03-23. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K152631.

When did MPO Total Knee Systems MR Labeling receive FDA 510(k) clearance?

MPO Total Knee Systems MR Labeling received FDA 510(k) clearance on 2016-03-23, under 510(k) number K152631.

Who is the listed applicant for MPO Total Knee Systems MR Labeling?

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 MPO Total Knee Systems MR Labeling?

The FDA product code for MPO Total Knee Systems MR Labeling is HRY.

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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 K233507EVOLUTION® Tibial Cones

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Dispositivos relacionados (Código: HRY)

K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UC K190633NanoOrtho NanoKnee® SystemNanoortho, LLC

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.