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510(k) Data Aggregation

    K Number
    K173910
    Device Name
    Impress SFS System
    Manufacturer
    Cable Fix Medical LLC
    Date Cleared
    2018-09-14

    (266 days)

    Product Code
    JDQ
    Regulation Number
    888.3010
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cable Fix Medical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Impress SFS System is indicated for general orthopaedic repair procedures. The Impress SFS System is also intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.
    Device Description
    The Impress SFS System is cable system which includes components such as cables and which are manufactured from stainless steel. These components are used together to address the indications as outlined in the next section. The implantable components in the Impress SFS System are provided sterile as indicated on the outer carton label.
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