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510(k) Data Aggregation

    K Number
    K060026
    Device Name
    KOBY SURGICAL INTERNAL FIXATION SYSTEM
    Manufacturer
    KOBY SURGICAL
    Date Cleared
    2006-01-26

    (22 days)

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

    KOBY SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Koby Surgical Internal Fixation System implants are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants are intended for single use only. These implants are not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
    Device Description
    The Koby Surgical Internal Fixation System consists of a series of cannulated and non-cannulated bone screws which vary in diameters and lengths. These screws are constructed from implant-grade titanium and are used to aid in the fixation of bones in the upper and lower extremities.
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