BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Syntec Femoral Nail Extended System

    K Number: K202935 · Decision Oct 28, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    302
    Registration Numbers
    302
    Same Product Code
    528
    Applicant Total
    6
    Review Days
    29

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    Basic Information

    Device Name
    Syntec Femoral Nail Extended System
    K Number
    K202935
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3020
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Syntec Scientific Corporation
    Date Received
    September 29, 2020
    Decision Date
    October 28, 2020
    Product Code
    HSB
    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
    HSB Rod, Fixation, Intramedullary And Accessories

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    Other Clearances by Syntec Scientific Corporation

    K Number Device Name
    K202790 Syntec Orthodontic Mini Screw Extended System
    K200933 Syntec Non-Sterile Steinmann Pins System
    K191617 Syntec Tibial Nail System
    K181296 Syntec Femoral Nail System
    K161327 SYNTEC HUMERAL NAIL SYSTEM