BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    40-42mm BiPolar Head and 22mm Femoral Head

    K Number: K163081 · Decision Jan 29, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    216
    Registration Numbers
    216
    Same Product Code
    98
    Applicant Total
    44
    Review Days
    452

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    Basic Information

    Device Name
    40-42mm BiPolar Head and 22mm Femoral Head
    K Number
    K163081
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3390
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Signature Orthopaedics Pty, Ltd.
    Date Received
    November 3, 2016
    Decision Date
    January 29, 2018
    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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