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

    HIP PIN

    K Number: K813340 · Decision Jan 29, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    37
    Applicant Total
    9
    Review Days
    65

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    Basic Information

    Device Name
    HIP PIN
    K Number
    K813340
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    The Deca Co.
    Date Received
    November 25, 1981
    Decision Date
    January 29, 1982
    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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    Other Clearances by The Deca Co.

    K Number Device Name
    K870041 FLEXIBLE FASCICULATED BONE PLATE
    K870040 INTRAMEDULLARY NAIL
    K863271 FASCICULATED S ROD
    K863215 FASCICULATED I ROD
    K863239 FASCICULATED BOAT ROD
    K861183 INTRAMEDULLARY ROD
    K854227 FASCILULATED NAIL
    K830087 INTRAMEDULLARY ROD