BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)

    K Number: K030972 · Decision May 30, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    103
    Applicant Total
    16
    Review Days
    63

    Basic Information

    Device Name
    FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)
    K Number
    K030972
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
    Date Received
    March 28, 2003
    Decision Date
    May 30, 2003
    Product Code
    KWL
    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
    KWL Prosthesis, Hip, Hemi-, Femoral, Metal

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