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

    BONE SCREWS

    K Number: K843554 · Decision Oct 1, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    37
    Applicant Total
    14
    Review Days
    21

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    Basic Information

    Device Name
    BONE SCREWS
    K Number
    K843554
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Mecron Medical Products, Inc.
    Date Received
    September 10, 1984
    Decision Date
    October 1, 1984
    Product Code
    KTW
    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
    KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

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    K844487 MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR
    K844486 MECRON MRC-HEADLESS FEMORAL COMPONENT
    K844773 EFF-EFFNER BULBS
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    K843553 BONE PLATES
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