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

    Kalitec Direct InSePtion™ MIS Fixation System

    K Number: K163471 · Decision Mar 16, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    47
    Applicant Total
    9
    Review Days
    94

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    Basic Information

    Device Name
    Kalitec Direct InSePtion™ MIS Fixation System
    K Number
    K163471
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3050
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kalitec Direct, LLC
    Date Received
    December 12, 2016
    Decision Date
    March 16, 2017
    Product Code
    PEK
    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
    PEK Spinous Process Plate

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