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

    Field Orthopaedics Micro Screw System

    K Number: K180348 · Decision Jul 17, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    3
    Review Days
    159

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    Basic Information

    Device Name
    Field Orthopaedics Micro Screw System
    K Number
    K180348
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Field Orthopaedics Pty, Ltd.
    Date Received
    February 8, 2018
    Decision Date
    July 17, 2018
    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
    K230118 Bony Trauma Extremity System (BTES) Screw Range, NX Nail
    K200043 Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range