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

    BARD ENDO LINK INTRACONDYLAR ROTATING

    K Number: K821476 · Decision Jun 23, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    137
    Registration Numbers
    137
    Same Product Code
    85
    Applicant Total
    645
    Review Days
    36

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    Basic Information

    Device Name
    BARD ENDO LINK INTRACONDYLAR ROTATING
    K Number
    K821476
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3510
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    C.R. Bard, Inc.
    Date Received
    May 18, 1982
    Decision Date
    June 23, 1982
    Product Code
    KRO
    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
    KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

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