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

    J-FX CERCLAGE SYSTEM

    K Number: K971682 · Decision Jun 27, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    7
    Applicant Total
    206
    Review Days
    52

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    Basic Information

    Device Name
    J-FX CERCLAGE SYSTEM
    K Number
    K971682
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Johnson & Johnson Professionals, Inc.
    Date Received
    May 6, 1997
    Decision Date
    June 27, 1997
    Product Code
    LRN
    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
    LRN Wire, Surgical

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