FDA 510(k)

LINK Endo-Model EVO Knee System

N.º K: K220628 · 2022-05-03

Fecha de decisión2022-05-03

Código de productoKRO

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

LINK Endo-Model EVO Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2022-05-03 under 510(k) number K220628. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the LINK Endo-Model EVO Knee System?

LINK Endo-Model EVO Knee System is a medical device that received FDA 510(k) clearance on 2022-05-03. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K220628.

When did LINK Endo-Model EVO Knee System receive FDA 510(k) clearance?

LINK Endo-Model EVO Knee System received FDA 510(k) clearance on 2022-05-03, under 510(k) number K220628.

Who is the listed applicant for LINK Endo-Model EVO Knee System?

The FDA 510(k) record lists Waldemar Link GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LINK Endo-Model EVO Knee System?

The FDA product code for LINK Endo-Model EVO Knee System is KRO.

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Otros registros que enlistan a Waldemar Link GmbH & Co. KG como solicitante

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)K250375Esbástil de Cadera Allure y Placas Intramedulares K243927MobileLink Acetabular Cup System - inhouse coatings K241636MobileLink Acetabular Cup System - Line Extension (Multiple)K231445LINK Embrace Shoulder System - Reverse Configuration K222066LINK MobileLink Acetabular Cup System

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Dispositivos relacionados (Código: KRO)

K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics K252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge BumperHowmedica Osteonics Corp., Dba Stryker Orthopaedics K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics K242871Rodilla de Bisagra Revision ATTUNE™Depuy Ireland UC 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 InseMicroport Orthopedics, Inc.

Fuente oficial

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