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    K Number
    K110541
    Device Name
    FIGURE 8 STERNOTOMY CLOSURE DEVICE
    Manufacturer
    FIGURE 8 SURGICAL, INCORPORATED
    Date Cleared
    2011-07-06

    (131 days)

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

    FIGURE 8 SURGICAL, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Figure 8 Sternotomy Closure Device is indicated for use in sternal closure procedures.
    Device Description
    The Figure 8 Sternotomy Closure Device ("Figure 8 SCD") is a permanent, medical grade 316L stainless steel implant intended for use in sternal closure following median sternotomy.
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