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

    DISCOVERY ELBOW - X-SMALL

    K Number: K090473 · Decision Mar 25, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    28
    Applicant Total
    93
    Review Days
    29

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    Basic Information

    Device Name
    DISCOVERY ELBOW - X-SMALL
    K Number
    K090473
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3150
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Manufacturing Corp
    Date Received
    February 24, 2009
    Decision Date
    March 25, 2009
    Product Code
    JDC
    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
    JDC Prosthesis, Elbow, Constrained, Cemented

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