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    K Number
    K072101
    Device Name
    RIGI-FIX HIP STEM SYSTEM
    Manufacturer
    IMPLANTS INTL. LTD.
    Date Cleared
    2007-11-19

    (111 days)

    Product Code
    LPHMEHTHE
    Regulation Number
    888.3358
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMPLANTS INTL. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RIGI-FIX™ Hip Stem System is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to femoral hip stem revisions.
    Device Description
    The RIGI-FIX™ Hip Stem System is a non-cemented acetabular cup system with a complete assortment of neutral and 10° hooded poly inserts as well as acetabular screws and screw hole covers (screw hole occluders).
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