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    K Number
    K103015
    Device Name
    ODRC-DYNAMIC HIP SCREW SYSTEM
    Manufacturer
    ORTHOPAEDIC DEVICE RESEARCH CENTER
    Date Cleared
    2011-04-13

    (183 days)

    Product Code
    KTTHRSHWC
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHOPAEDIC DEVICE RESEARCH CENTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ODRC-DHS System is intended for use in fixation of fractures to the proximal femur. The system is indicated for use in trochanteric, pertrochanteric, intertrochanteric, and basilar neck fractures.
    Device Description
    The ODRC-Dynamic Hip Screw System consists of non-sterile ODRC-DHS Plate, ODRC-DHS Screw, ODRC-DHS Blades, compression screw, and 4.5 mm cortex screw. The ODRC-DHS Plate is a straight with an angled barrel portion that accepts ODRC-DHS Screw and ODRC-DHS Blades. The barrel angle is 135° and length of 36 mm. The plates are available in multiple lengths (lengths ranging from 46 mm to 206 mm) to accommodate differing patient anatomy. The plate accepts DHS Helix Screw (lengths ranging from 75 mm to 130 mm) and 4.5 mm cortex screws.
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