BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Micro Screw (various sizes)

    Reg #: 3015131017 · FEI: 3015131017 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    FIELD ORTHOPAEDICS
    Registration Number
    3015131017
    FEI Number
    3015131017
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    30 Florence Street
    City
    Teneriffe Queensland
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K180348

    Owner / Operator

    Firm Name
    Field Orthopaedics Pty Ltd
    Operator Number
    10058631
    Address
    30 Florence Street
    City
    Teneriffe
    State
    Queensland
    Postal Code
    4005
    Country
    AU
    Correspondent
    Jillianne McKenzie

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Pin, Fixation, Smooth HTY
    Screw, Fixation, Bone HWC

    Proprietary Names

    Micro Screw (various sizes) K-wire (various)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility