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510(k) Data Aggregation

    K Number
    K063020
    Device Name
    INTAI BONE PLATE AND BONE SCREW SYSTEM; INTAI DHS/DCS PLATE SYSTEM
    Manufacturer
    INTAI TECHNOLOGY INC.
    Date Cleared
    2006-12-14

    (73 days)

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

    INTAI TECHNOLOGY INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bone Plate and Bone Screw System and the DHS/DCS Plate System are provided non-sterile. The Bone Plate and Bone Screw System is intended for use in fixation of fractures to the various bones, including the clavicle, pelvis, scapula, calcaneus, long bone (humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and phalanges). The DHS/DCS Plate 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 Bone Plate and Bone Screw System & the DHS/DCS Plate System consist of non-sterile bone plate and bone screw implants. The plates are devices, which are fastened to bone for purpose of providing fixation. The plates are provided in various types according to different function. Thus there are four kind of styles : Dynamic Compression Plate (DCP), tubular, special and DHS/DCS. The shape of the plate is an adaptation of the plate to the local anatomy and doesn't denote any function. Thus the name depends on the biomechanical function the plate is performing. The plates are divided various types as following: DCP, Tubular, Special, DHS/DCS. The series in size of bone screw and bone plate except DHS/DCS are divided into mini, small and large. The size range of plates are in thickness from 1.0 to 6.0mm, width from 3.8 to 17mm, length from 17 to 359mm, and hole number from 2 to 22 holes. On the other hand, the screws used cither to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone. The screws are differentiated by the manner in which they are inserted into bone, their size, and the type of bone they are intended for. Thus there are four kind of style : cancellous, malleolar and cannulated screws. All screws have a hex::gonal recess this feature has proven itself to be of grate advantage at the time of the screw removal and insertion. The size range of screws is in thread diameter from 1.5 to 7.3 mm, total length from 6 to 150mm. The DHS/DCS Plate System consists of DHS/DCS Plate, DHS/DCS Screw, DHS/DCS Compression Screw, and 4.5mm Cortex Screw (self-tapping). The DHS Plates are available with short and standard barrel which length is 25mm and 38mm respectively. And the barrel angles are available in 95°, 135°, 140°, 145° and. 150°. The self-tapping 4.5mm Cortex Screw can be used to fix the DHS/DCS Plate to the femoral shaft. The DHS/DCS Screw is available in total length from 50 to 145 mm, thread length 22mm, shaft diameter 7.9mm, and outer diameter from 12.5 to 14mm. The thread of DHS/DCS Screw has a buttress type. The DHS/DCS Compression Screw can be used to achieve fracture compression. Its dimension is available with thread length 26mm and outer diameter 4.0 mm.
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