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    K Number
    K241769
    Device Name
    Response Ortho Metaphyseal Hinge Fixator System
    Manufacturer
    Response Ortho Solutions LLC
    Date Cleared
    2024-09-18

    (90 days)

    Product Code
    KTT
    Regulation Number
    888.3030
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    Applicant Name (Manufacturer) :

    Response Ortho Solutions LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Response Ortho Metaphyseal Fixation System is indicated for treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation.
    Device Description
    The Response Ortho Metaphyseal Hinge Fixator System is a unilateral fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. The system is designed to provide low profile and comprehensive solution invasively. Implants, reusable instruments, accessories, case&tray are included in the system. Products are non-sterile and implants that exist in the set, are single use. Instruments that are in the system, can be used repeatedly after cleaning and sterilization.
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