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510(k) Data Aggregation

    K Number
    K071637
    Device Name
    INTRINSIC THERAPEUTICS FIXATION STAPLE
    Manufacturer
    INTRINSIC THERAPEUTICS INCORPORATED
    Date Cleared
    2007-08-03

    (49 days)

    Product Code
    JDR
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTRINSIC THERAPEUTICS INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Intrinsic Therapeutics Fixation Staple is intended for providing soft tissue fixation to bone in orthopedic procedures such as: 1. Tendon repairs, transfers, or transplants, such as in the treatment of paralytic conditions, tendon avulsions or ruptures, in which the tendon is fixed to the bone. 2. Ligament repairs, reconstruction, or replacement in which the ligament is fixed to the bone.
    Device Description
    The Intrinsic Therapeutics Fixation Staple is made from 6Al 4V ELI Titanium conforming to ASTM F136. The legs of the staple have barbs and are curved to provide strength in bone fixation. The staple is provided sterile. A reusable insertion tool is provided to facilitate insertion of the staple.
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