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510(k) Data Aggregation

    K Number
    K041353
    Device Name
    FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM
    Manufacturer
    JRI MANUFACTURING LTD
    Date Cleared
    2004-10-08

    (141 days)

    Product Code
    MEH
    Regulation Number
    888.3353
    Why did this record match?
    Applicant Name (Manufacturer) :

    JRI MANUFACTURING LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Indications for the Furloug® H-AC Total Hip Replacement System are: - Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. - Rheumatoid arthritis . - Correction off functional deformity . - Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. - Revision procedures where other treatments or devices have failed. .
    Device Description
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