FDA 510(k)

EVOLUTION® Cement Keel

Número K: K231947 · 2023-10-31

Data da decisão2023-10-31

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

EVOLUTION® Cement Keel 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 2023-10-31 under 510(k) number K231947. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EVOLUTION® Cement Keel?

EVOLUTION® Cement Keel is a medical device that received FDA 510(k) clearance on 2023-10-31. The listed applicant is Microport Orthopedics, Inc.. The 510(k) number is K231947.

When did EVOLUTION® Cement Keel receive FDA 510(k) clearance?

EVOLUTION® Cement Keel received FDA 510(k) clearance on 2023-10-31, under 510(k) number K231947.

Who is the listed applicant for EVOLUTION® Cement Keel?

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® Cement Keel?

The FDA product code for EVOLUTION® Cement Keel is JWH.

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Outros registros que listam Microport Orthopedics, Inc. como candidato(a)

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

Ver todos os 28 dispositivos →

Dispositivos Relacionados (Código: JWH)

K262057GMK ExtensionMedacta International SA K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Sistema de Quadril de RevisãoDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

Fonte oficial

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