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510(k) Data Aggregation

    K Number
    K141045
    Device Name
    MBD PLATE SYSTEM
    Manufacturer
    MBD MEDICAL, LLC
    Date Cleared
    2014-06-30

    (68 days)

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

    MBD MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MBD Plate System is intended for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.
    Device Description
    The MBD Plate System is a titanium plating system comprised of various length plates and screws. The plates are low profile straight plates ranging in length from 72mm to 136mm. The plate thickness and width are 3mm and 11mm, respectively. Plate sizes are from 6 to 11 holes and each plate hole and/or slot accepts 4.0mm non-locking bone screws. Bone screws range from 12 to 24mm in length. Additionally, the system comprises low-profile 2.5mm diameter fragment screws in lengths from 10 to 24mm.
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