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

    BARNES FEMORAL LENGTHENING DEVICE

    K Number: K895243 · Decision Aug 10, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    1
    Review Days
    354

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    Basic Information

    Device Name
    BARNES FEMORAL LENGTHENING DEVICE
    K Number
    K895243
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Piedmont Sports Medicine & Orthopaedic Clinic
    Date Received
    August 21, 1989
    Decision Date
    August 10, 1990
    Product Code
    HRS
    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
    HRS Plate, Fixation, Bone

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