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510(k) Data Aggregation

    K Number
    K080542
    Device Name
    DISTRAX
    Manufacturer
    JOHN W. KING
    Date Cleared
    2008-12-15

    (292 days)

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

    JOHN W. KING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Distrax is intended for mandibular symphyseal widening and mandibular lengthening by distraction osteogenesis. Following the distraction osteogenesis, the Distrax may also be used for temporary stabilization during the consolidation phase. The Distrax is intended for single patient use only.
    Device Description
    Distrax™ is a preassembled distraction system consisting of the following major components: Distraction Screw, Distractor Arms, Fixed Screw, Threaded Tube, Locknut (optional). Titanium Bone Screws (K063298) and brackets (surgical stainless steel, 24 gauge) are required for use and should be obtained by the surgeon and orthodontist, respectively. An Activation Key is also supplied to turn the Distraction Screw. The patient contact materials of the Distrax are made of austenitic stainless steel type 304 (chromium-nickel stainless class) and type 316 (chromium-nickel class containing 2-3% molybdenum). These materials are specified in ISO standards 5832-1 and 5832-9 for medical implant applications. The device must be cleaned and sterilized before use.
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