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

    OSTEONICS FX-CABLELOK GRIP COMPONENTS

    K Number: K980594 · Decision May 5, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    8
    Applicant Total
    178
    Review Days
    77

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    Basic Information

    Device Name
    OSTEONICS FX-CABLELOK GRIP COMPONENTS
    K Number
    K980594
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osteonics Corp.
    Date Received
    February 17, 1998
    Decision Date
    May 5, 1998
    Product Code
    LYT
    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
    LYT Fixation Accessory

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