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

    TRICON REVISION TOTAL KNEE SYSTEM

    K Number: K844706 · Decision Feb 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    113
    Applicant Total
    71
    Review Days
    78

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    Basic Information

    Device Name
    TRICON REVISION TOTAL KNEE SYSTEM
    K Number
    K844706
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3520
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Richards Medical Co., Inc.
    Date Received
    December 3, 1984
    Decision Date
    February 19, 1985
    Product Code
    HSX
    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
    HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

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