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510(k) Data Aggregation

    K Number
    K183317
    Device Name
    AdvantageRib System
    Manufacturer
    SIG Medical Corporation
    Date Cleared
    2019-02-14

    (76 days)

    Product Code
    HRS, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIG Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AdvantageRib System is intended for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.
    Device Description
    The AdvantageRib System consists of bridges (with locking posts) and locking caps for the thoracoscopic fixation and stabilization of ribs. These implants are manufactured from commercially pure titanium and titanium alloys (Ti-6Al-7N per ASTM F1295 and Ti-6Al-4V per ASTM F136 or ASTM F1472). The system is comprised of the following implants: - Titanium alloy AdvantageRib Bridge with threaded locking posts - Commercially pure locking caps When fully assembled, the bridge is placed on the underside of the rib, the threaded locking posts extends through pre-drilled holes in the rib, and the locking caps are fixed to the locking post on the anterior side of the rib. The combined threaded locking post/locking cap provides for fixation of the bridge.
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