BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    Pelion Stem

    Reg #: 3008262872 · FEI: 3008262872 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    4

    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
    K133370

    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
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH

    Proprietary Names

    Pelion Stem Pegasus Stem Evolve Masters Stem Remedy Stem Distal Centraliser Cement Plug Evolve Helios Stem Bipolar Head SKYLON Stem Encina Taper A

    Establishment Types

    Manufacture Medical Device