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    K Number
    K991732
    Device Name
    CENTRAFIX EXTERNAL FIXATOR
    Manufacturer
    OWANDAR MEDICAL LTD
    Date Cleared
    1999-05-21

    (0 days)

    Product Code
    JECANDHTY
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    OWANDAR MEDICAL LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Fixation of orthopaedic fractures to long bones and the pelvis involving severe trauma with loss or damage to soft tissues, infection and/or loss of bone stock.
    Device Description
    Centrafix® External Fixator
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