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510(k) Data Aggregation

    K Number
    K082017
    Device Name
    STARR FRAME STEINMANN PIN
    Manufacturer
    Date Cleared
    2008-10-10

    (86 days)

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

    STARR FRAME LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Starr Frame Steinmann Pins are non-sterile, single use, fixation devices intended for use in fixation of bone fractures, for bone reconstructions, and implantation through the skin so that traction may be applied to the skeletal system.
    Device Description
    The Starr Frame Steinmann Pins consist of various fixation pins and are offered in assorted dimensions and configurations to accommodate physician preferences, physical profiles of different patients, and varying injuries and conditions. The devices are constructed of implant grade 316LVM stainless steel. They are provided non-sterile and intended for single-use only.
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