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

    ARIZONA RADIO CAPITELLAR TOTAL ELBOW

    K Number: K812322 · Decision Jan 4, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    26
    Applicant Total
    376
    Review Days
    140

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    Basic Information

    Device Name
    ARIZONA RADIO CAPITELLAR TOTAL ELBOW
    K Number
    K812322
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3160
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Zimmer, Inc.
    Date Received
    August 17, 1981
    Decision Date
    January 4, 1982
    Product Code
    JDB
    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
    JDB Prosthesis, Elbow, Semi-Constrained, Cemented

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