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

    UNICONDYLAR FIBER METAL KNEE

    K Number: K834298 · Decision Feb 13, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    90
    Applicant Total
    376
    Review Days
    67

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    Basic Information

    Device Name
    UNICONDYLAR FIBER METAL KNEE
    K Number
    K834298
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3530
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Zimmer, Inc.
    Date Received
    December 8, 1983
    Decision Date
    February 13, 1984
    Product Code
    HRY
    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
    HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

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