BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    LINK Endo-Model EVO Knee System

    K Number: K220628 · Decision May 3, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    82
    Applicant Total
    25
    Review Days
    60

    Basic Information

    Device Name
    LINK Endo-Model EVO Knee System
    K Number
    K220628
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3510
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Waldemar Link GmbH & Co. KG
    Date Received
    March 4, 2022
    Decision Date
    May 3, 2022
    Product Code
    KRO
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

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