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

    Klassic BiPolar System

    K Number: K143113 · Decision Jan 28, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    216
    Registration Numbers
    216
    Same Product Code
    98
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    Klassic BiPolar System
    K Number
    K143113
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3390
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Total Joint Orthopedics
    Date Received
    October 30, 2014
    Decision Date
    January 28, 2015
    Product Code
    KWY
    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
    KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

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