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

    AXIAL AND OFFSET CROSSLINK PLATES

    K Number: K896740 · Decision Feb 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    321
    Same Product Code
    429
    Applicant Total
    56
    Review Days
    88

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    Basic Information

    Device Name
    AXIAL AND OFFSET CROSSLINK PLATES
    K Number
    K896740
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Danek Medical, Inc.
    Date Received
    November 30, 1989
    Decision Date
    February 26, 1990
    Product Code
    KWP
    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
    KWP Appliance, Fixation, Spinal Interlaminal

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