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    K Number
    K092381
    Device Name
    IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION
    Manufacturer
    IBALANCE MEDICAL, INC.
    Date Cleared
    2009-10-27

    (83 days)

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

    IBALANCE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iBalance AKRxx Medial Opening Wedge Tibial System includes instrumentation, implant, and fixation and is used to provide fixation following Proximal Tibial opening wedge osteotomies. It is intended to be used with adequate post-operative immobilization.
    Device Description
    The iBalance AKRFx Medial Opening Wedge Tibial System is comprised of an instrumentation set (AKRFX Medial Instrumentation), a PEEK wedge-like implant (the iFX® Medial PEEK Implant) and PEEK fixation (the iFX® Medial PEEK Cancellous and Cortical Anchors). The system enables surgeons to perform a high tibial opening wedge osteotomy with fixation. The iFX® Medial PEEK Implant is provided in three general sizes; Small (SM), Medium (MD), and Large (LG). Two configurations of implant and anchors exist. The implant and anchors work as a single construct to fixate and support the opening wedge at its corrective angle.
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