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

    PHANTOM FIBER BIOFIBER SUTURE

    K Number: K130422 · Decision Apr 4, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    51
    Review Days
    43

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    Basic Information

    Device Name
    PHANTOM FIBER BIOFIBER SUTURE
    K Number
    K130422
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4494
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tornier, Inc.
    Date Received
    February 20, 2013
    Decision Date
    April 4, 2013
    Product Code
    NWJ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NWJ Suture, Recombinant Technology

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