BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Instruments for LINK MEGASYSTEM-C Family

    K Number: K190181 · Decision Oct 25, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    85
    Applicant Total
    2
    Review Days
    266

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    Basic Information

    Device Name
    Instruments for LINK MEGASYSTEM-C Family
    K Number
    K190181
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3510
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    LinkBio Corp.
    Date Received
    February 1, 2019
    Decision Date
    October 25, 2019
    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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    Other Clearances by LinkBio Corp.

    K Number Device Name
    K241470 CORE Shoulder System