BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Dymaxeon Spine System

    Reg #: 3008262872 · FEI: 3008262872 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    SIGNATURE ORTHOPAEDICS PTY LIMITED
    Registration Number
    3008262872
    FEI Number
    3008262872
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7 Sirius Road, Lane Cove West
    City
    Sydney New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K150184

    Owner / Operator

    Firm Name
    Signature Orthopaedics Pty Limited
    Operator Number
    10037793
    Address
    7 Sirius Road
    City
    Lane Cove West
    State
    New South Wales
    Postal Code
    2066
    Country
    AU
    Correspondent
    Declan P Brazil

    Products

    Device Name Product Code
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    Dymaxeon Spine System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)