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

    CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS

    K Number: K983141 · Decision Nov 6, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    26
    Applicant Total
    206
    Review Days
    59

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    Basic Information

    Device Name
    CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS
    K Number
    K983141
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3160
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Johnson & Johnson Professionals, Inc.
    Date Received
    September 8, 1998
    Decision Date
    November 6, 1998
    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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