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510(k) Data Aggregation

    K Number
    K161904
    Device Name
    GEO Bone Screw System
    Manufacturer
    GRAMERCY EXTREMITY ORTHOPEIDICS, LLC
    Date Cleared
    2017-01-18

    (191 days)

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

    GRAMERCY EXTREMITY ORTHOPEIDICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GEO Bone Screw System is indicated for bone fractures, arthrodesis, osteochondritis, and tendon reattachment.
    Device Description
    The GEO Bone Screw System implants include cannulated and solid, low-profile headed and headless, partial and fully threaded bone screws in a variety of diameters and lengths. Optional washers, correspondingly sized to each bone screw, are available as well as k-wires and general orthopedic instruments. GEO implants are comprised of titanium alloy. The GEO Bone Screw System is provided sterile by exposure to gamma irradiation.
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