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510(k) Data Aggregation

    K Number
    K182179
    Device Name
    AdvantageRib Anterior System
    Manufacturer
    SIG Medical Corp.
    Date Cleared
    2018-11-16

    (95 days)

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

    SIG Medical Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AdvantageRib Anterior System is intended for the fixation, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.
    Device Description
    The AdvantageRib Anterior System is composed of commercially pure titanium locking bone plates per ASTM F67 and titanium alloy locking and non-locking screws per ASTM F1472 that provide rigid fixation in instances of fractures and osteotomies in normal and osteoporotic bone. The implant and associated screws are provided to the end user in non-sterile packaging, in a variety of sizes and lengths.
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