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

    PROSTHETIC - FEMORAL HIP COMPONENT

    K Number: K871462 · Decision Jun 4, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    1
    Review Days
    51

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    Basic Information

    Device Name
    PROSTHETIC - FEMORAL HIP COMPONENT
    K Number
    K871462
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Louis A. Serafin, Jr., M.D.
    Date Received
    April 14, 1987
    Decision Date
    June 4, 1987
    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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