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

    TITAN 3-D™ Wedge System

    K Number: K162241 · Decision Apr 3, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    17
    Applicant Total
    7
    Review Days
    236

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    Basic Information

    Device Name
    TITAN 3-D™ Wedge System
    K Number
    K162241
    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
    Date Received
    August 10, 2016
    Decision Date
    April 3, 2017
    Product Code
    PLF
    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
    PLF Bone Wedge

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