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

    Phantom Small Bone Intramedullary Nail System

    K Number: K170693 · Decision Jun 19, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    37
    Applicant Total
    50
    Review Days
    104

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    Basic Information

    Device Name
    Phantom Small Bone Intramedullary Nail System
    K Number
    K170693
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Paragon 28, Inc.
    Date Received
    March 7, 2017
    Decision Date
    June 19, 2017
    Product Code
    KTW
    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
    KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

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