BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    Bony Trauma Extremity System (BTES) Screw Range, NX Nail

    K Number: K230118 · Decision Feb 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    3
    Review Days
    30

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    Basic Information

    Device Name
    Bony Trauma Extremity System (BTES) Screw Range, NX Nail
    K Number
    K230118
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Field Orthopaedics Pty, Ltd.
    Date Received
    January 17, 2023
    Decision Date
    February 16, 2023
    Product Code
    HWC
    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
    HWC Screw, Fixation, Bone

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    Other Clearances by Field Orthopaedics Pty, Ltd.

    K Number Device Name
    K200043 Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range
    K180348 Field Orthopaedics Micro Screw System