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

    FERNORAL HIP PROSTHESIS

    K Number: K803074 · Decision Jan 8, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    227
    Registration Numbers
    227
    Same Product Code
    562
    Applicant Total
    7
    Review Days
    34

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    Basic Information

    Device Name
    FERNORAL HIP PROSTHESIS
    K Number
    K803074
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3350
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Cintor Orthopaedic Div.
    Date Received
    December 5, 1980
    Decision Date
    January 8, 1981
    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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    Other Clearances by Cintor Orthopaedic Div.

    K Number Device Name
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    K810353 HARRIS CEMENT RESTRICTOR
    K803106 AGINSKY NAIL
    K802627 ORTRON 90* HIP PROSTHESIS
    K802814 ORTHOFIX AXIALEXTERNAL FIXATION SYS.