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

    Tritium® Sternal Cable Plate System

    K Number: K161876 · Decision Sep 9, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    155
    Registration Numbers
    155
    Same Product Code
    128
    Applicant Total
    6
    Review Days
    63

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    Basic Information

    Device Name
    Tritium® Sternal Cable Plate System
    K Number
    K161876
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3010
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
    Date Received
    July 8, 2016
    Decision Date
    September 9, 2016
    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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