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

    SPHERISTEM TOTAL HIP PROSTHESIS

    K Number: K780497 · Decision Jun 14, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    58
    Applicant Total
    6
    Review Days
    78

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    Basic Information

    Device Name
    SPHERISTEM TOTAL HIP PROSTHESIS
    K Number
    K780497
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3360
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    American Ortomed Corp.
    Date Received
    March 28, 1978
    Decision Date
    June 14, 1978
    Product Code
    JDG
    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
    JDG Prosthesis, Hip, Femoral Component, Cemented, Metal

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    Other Clearances by American Ortomed Corp.

    K Number Device Name
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    K840413 CEMENT RESTRICTOR
    K820719 THE ICR KNEE