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    K Number
    K210247
    Device Name
    OsteoCentric Integrated Hip Fastener System
    Manufacturer
    OsteoCentric Technologies d.b.a. OsteoCentric Trauma
    Date Cleared
    2021-04-30

    (91 days)

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

    OsteoCentric Trauma

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OsteoCentric Integrated Hip Fastener System is intended to treat stable and unstable intertrochanteric, subtrochanteric, and basilar neck fractures in which a stable medial buttress can be reconstructed.
    Device Description
    The OsteoCentric Integrated Hip Fastener System is intended for use in internal fixation of femoral neck fractures. The OsteoCentric Integrated Hip Fastem consist of plates and screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The devices are provided non-sterile. All implantable devices are manufactured from Stainless Steel per ASTM F138.
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    K Number
    K190430
    Device Name
    OsteoCentric Bone Plate and Screw System
    Manufacturer
    OsteoCentric Trauma
    Date Cleared
    2019-03-22

    (28 days)

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

    OsteoCentric Trauma

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OsteoCentric Bone Plate and Screw is intended for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, but not limited to periarticular, and intraarticular fractures
    Device Description
    The OsteoCentric Bone Plate and Screw System consists of implants and instruments designed for fixation to treat fractures, deformations, revisions and replantations of bones and bone fragments. The system features nineteen (19) types of plates and bone screws for fixation that are locking or non-locking, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel (ASTM F138), and offered in various widths and lengths.
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