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510(k) Data Aggregation

    K Number
    K062739
    Device Name
    CINCH BONE ANCHOR SYSTEM
    Date Cleared
    2007-02-13

    (153 days)

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

    SAPPHIRE MEDICAL, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CINCH Bone Anchor System is intended to be used for fixation of soft tissue to bone during rotator cuff repair.
    Device Description
    The CINCH Bone Anchor System provides surgeons with a fixation anchor that can be used during arthroscopic shoulder procedures. The device is available in two configurations, the CINCH WRC Anchor and the CINCH RRC Anchor. Both configurations are provided pre-loaded in a delivery instrument. The CINCH WRC Anchor configuration is comprised of a curved PEEK base, a flared nitinol clip, two nitinol laser cut rings and a nitinol anchor pin. The device is preloaded in the CINCH Inserter The CINCH RRC Anchor, is comprised of a machine molded cylindrical PEEK base, two nitinol laser cut rings and a nitinol anchor pin This device is also preloaded in a CINCH Inserter. The design of the CINCH Bone Anchors is intended to permit surgeons to have direct tactile feedback of the tension in the suture between the tissue and the bone. Additionally, the CINCH Anchors are designed to allow the two ends of a suture to be individually adjusted. This permits the surgeon to fine-tune the placement of the tissue with respect to the bone, and then secure the suture without tying a knot.
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