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

    MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA

    K Number: K002324 · Decision Aug 24, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    5
    Review Days
    24

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    Basic Information

    Device Name
    MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA
    K Number
    K002324
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sulzermedica
    Date Received
    July 31, 2000
    Decision Date
    August 24, 2000
    Product Code
    JDI
    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
    JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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