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

    FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)

    K Number: K014072 · Decision Mar 8, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    216
    Registration Numbers
    216
    Same Product Code
    98
    Applicant Total
    16
    Review Days
    88

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    Basic Information

    Device Name
    FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)
    K Number
    K014072
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3390
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Disc-O-Tech Medical Technologies, Ltd.
    Date Received
    December 10, 2001
    Decision Date
    March 8, 2002
    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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