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

    STROPP (Single Tunnel Repair of Plantar Plate)

    K Number: K160118 · Decision May 3, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    593
    Applicant Total
    13
    Review Days
    105

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    Basic Information

    Device Name
    STROPP (Single Tunnel Repair of Plantar Plate)
    K Number
    K160118
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Crossroads Extremity Systems, LLC
    Date Received
    January 19, 2016
    Decision Date
    May 3, 2016
    Product Code
    MBI
    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
    MBI Fastener, Fixation, Nondegradable, Soft Tissue

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