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    K Number
    K132104
    Device Name
    ELIBRA SOFT-TISSUE FORCE SENSOR
    Manufacturer
    Kamm & Associates
    Date Cleared
    2014-03-21

    (256 days)

    Product Code
    ONN
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Kamm **& Associates

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The force sensor is sterile. for single patient use.
    Device Description
    The device consists of one unit, containing the force sensor and an electronic display. The eLIBRA® Soft-Tissue Force Sensor for a total knee replacement is a single use battery powered device designed to show relative forces on the integrated display. The eLIBRA® Unit is a non-reusable battery powered device designed to receive an electronic signal from the integrated force sensor. The unit displays a number from 0-20 for both the medial and lateral compartments in the knee joint to aid the surgeon in balancing soft tissue structures during a total knee arthroplasty (TKA).
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