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    K Number
    K032520
    Device Name
    ORTRAUTEK TRAUMA SYSTEM
    Manufacturer
    TEKKA
    Date Cleared
    2003-11-12

    (89 days)

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

    TEKKA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORTRAUTEK TRAUMA SYSTEM is a cranio-maxillofacial titanium plate and screw system intended for osteotomy, stabilization and rigid fixation of cranio-maxillofacial fracture and reconstruction.
    Device Description
    The ORTRAUTEK TRAUMA SYSTEM is composed of bone plates and bone screws of various shapes and sizes, and associated accessories for use in oral and maxillofacial surgery. The accessories include the instruments used to implant bone plates and screws. These accessories include screwdrivers, forceps, and drills. The bone plates meet ASTM F67 standards of unalloved titanium surgical implants. The bone screws meet ASTM F136 standards. The system contains various shapes and sizes of plates. The thickness of these plates is either 1.0 mm or 0.6 mm. The system contains bone screws that are 2.0 mm, 2.4 mm, or 1.5 mm.
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    K Number
    K031989
    Device Name
    ORTRAUTEK ORTHOGNATHIC SYSTEM
    Manufacturer
    TEKKA
    Date Cleared
    2003-10-28

    (123 days)

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

    TEKKA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ORTRAUTEK ORTHOGNATHIC SYSTEM is intended for oral, maxillofacial surgery: selective trauma, reconstructive surgery, and selective orthognathic surgeries on maxilla and mandible.
    Device Description
    The ORTRAUTEK ORTHOGNATHIC SYSTEM is composed of bone plates and bone screws of various shapes and sizes, and associated accessories for use in oral and maxillofacial surgery. The accessories include the instruments used to implant bone plates and screws. These accessories include screwdrivers, forceps, and drills. The bone plates meet ASTM F67 standards of unalloyed titanium surgical implants. The bone screws meet ASTM F136 standards. The system contains various shapes and sizes of plates. The thickness of these plates is either 1.0 mm, 0.6 mm, or 0.8 mm. The system contains bone screws that are 2.0 mm, 2.4 mm, or 1.5MM.
    Ask a Question

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