BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    FIGURE 8 STERNOTOMY CLOSURE DEVICE

    K Number: K110541 · Decision Jul 6, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    128
    Applicant Total
    1
    Review Days
    131

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    Basic Information

    Device Name
    FIGURE 8 STERNOTOMY CLOSURE DEVICE
    K Number
    K110541
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3010
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Figure 8 Surgical, Incorporated
    Date Received
    February 25, 2011
    Decision Date
    July 6, 2011
    Product Code
    JDQ
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JDQ Cerclage, Fixation

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