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

    LINK CERCLAGE WIRE SYSTEM

    K Number: K970084 · Decision Mar 13, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    128
    Applicant Total
    26
    Review Days
    63

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    Basic Information

    Device Name
    LINK CERCLAGE WIRE SYSTEM
    K Number
    K970084
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3010
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Turnkey Intergration USA, Inc.
    Date Received
    January 9, 1997
    Decision Date
    March 13, 1997
    Product Code
    JDQ
    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
    JDQ Cerclage, Fixation

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