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510(k) Data Aggregation

    K Number
    K130613
    Device Name
    CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM
    Manufacturer
    Date Cleared
    2014-01-22

    (321 days)

    Product Code
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAURA CATTABRIGA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Intended Use of the Cannulated Screw and Kirschner (Kwire) System is for the treatment and fixation of bone fractures and osteotomies of various bones including the, acetabulum, pelvis, humerus, radius, ulna, femur, tibia, phalanges, carpals, metacarpals, tarsals, metatarsals and fibula
    Device Description
    Cannulated Screws and Kwires are a self-tapping, self-drilling screw with a cortico/cancellous or cancellous thread that can be guided into position by Kwire placement. Partial or fully threaded screws are available in various different lengths and diameters to provide fixation in various size bones. The screws are made of Stainless Steel. The Kirschner Wires (Kwires) are threaded, spaded or blunt ranging from 0.8mm to 1.4mm of an inch in diameter and 150mm in length and made of 316L Stainless Steel.
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    K Number
    K130614
    Device Name
    BONE FRAGMENT AND FIXATION PLATES, SCREWS AND WASHERS
    Manufacturer
    Date Cleared
    2014-01-17

    (316 days)

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

    LAURA CATTABRIGA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Core Orthopaedics bones plates and screws system are intended to be used for internal fixation of bone fractures, fusions or osteotomies in the ankle, foot, hand, wrist, clavicle, scapula, pelvis, long bone (such as humerus, ulna, radius, femur, tibia, and fibula, and small bones (such as metacarpals, metatarsals, phalanges). The washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of large bone and bone fragments.
    Device Description
    The bone fragment fixation plates and washers of various sizes, consists of various shapes as well as screws are intended to treat fractures and osteotomies of various bones. including the clavicle, acetabulum, pelvis, scapula, humerus, radius, ulna, femur, tibia, phalanges, carpals, metacarpals, tarsals, metatarsals and fibula. The washers are to function with screws to prevent the screw head from breaking through the cortex of the bone by providing additional surface area during screw placement. The plates, screws, and washers are a one-piece device made of stainless steel.
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