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    K Number
    K182609
    Device Name
    Delphos Implants Rigid Fixation System
    Manufacturer
    Delphos Implants - Ind.Com. Importacao e Exportacao de
    Date Cleared
    2019-03-29

    (189 days)

    Product Code
    JEY
    Regulation Number
    872.4760
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    Applicant Name (Manufacturer) :

    Delphos Implants - Ind.Com. Importacao e Exportacao de

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Delphos Implants Rigid Fixation System is intended for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction. The Delphos Implants Rigid Fixation System implants are intended for single use only.
    Device Description
    The plates are manufactured in commercially pure titanium (ASTM F67 and ISO 5832-2) and the bone screws are manufactured from titanium alloy Ti-4Al-6V ELI (ASTM F136 and ISO 5832-3) and are available on different sizes, according with the site of the implantation and the extension of the fracture. The devices are for single use, provided non-sterile, must be properly cleaned, disinfected and sterilized before use, according the recommendations provided on the Instructions for Use provided by Delphos Implants. The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in maxillofacial surgery and/or stomatology.
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