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    K Number
    K073307
    Device Name
    MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM
    Manufacturer
    BIO-TECHNOLOGY USA, INC.
    Date Cleared
    2008-10-29

    (341 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-TECHNOLOGY USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MaxFace Maxillofacial Ostheosynthesis System is indicated for trauma fixation of the superior, middle and inferior segments of the facial skeleton, for ostheosynthesis of corrective osteotomies in congenital deformities treatment (acquired or in development) and for the fixation of grafts in reconstructive surgeries.
    Device Description
    The MaxFace Maxillofacial Ostheosynthesis System is composed of plates and screws, which are available in four different kit sizes: Cranio, Micro, Standard, and Macro systems.
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