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

    ZIMMER NEXEL TOTAL ELBOW

    K Number: K123862 · Decision Mar 12, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    28
    Applicant Total
    376
    Review Days
    88

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    Basic Information

    Device Name
    ZIMMER NEXEL TOTAL ELBOW
    K Number
    K123862
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3150
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zimmer, Inc.
    Date Received
    December 14, 2012
    Decision Date
    March 12, 2013
    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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