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

    Dunamis Force DFX Tensile Tape

    K Number: K153746 · Decision Mar 3, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    242
    Registration Numbers
    242
    Same Product Code
    173
    Applicant Total
    6
    Review Days
    65

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    Basic Information

    Device Name
    Dunamis Force DFX Tensile Tape
    K Number
    K153746
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5000
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dunamis, LLC
    Date Received
    December 29, 2015
    Decision Date
    March 3, 2016
    Product Code
    GAT
    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
    GAT Suture, Nonabsorbable, Synthetic, Polyethylene

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    Other Clearances by Dunamis, LLC

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    K160996 Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm
    K151220 Dunamis Interference Screw
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