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510(k) Data Aggregation

    K Number
    K140875
    Device Name
    OPTOSSOL COMPRESSION DEVICE SYSTEM
    Manufacturer
    Date Cleared
    2014-05-30

    (56 days)

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

    GENOSSIS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OptOssol™ Compression Device System is indicated for use in the internal fixation of fractures, fusions and revisions. The system is intended for but not limited to hand surgery, orthopedic surgery and podiatric surgery - but is not intended for Spinal Use.
    Device Description
    The GenOssis OptOssol™ Compression Device System implants consists of screws designed to compact juxtaposed bone fragments in compression to enhance bone healing and fusion through the immobilization of the fragments with or without the use of bone graft. The wires are inserted using standard wire drivers present in the operating room and compression is conducted using the provided driver. The partially threaded Wires are available with a Sleeve, and in various diameters and lengths to accommodate patient anatomy.
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