BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Origin Coxa Vara Stem

    Reg #: 3014763043 · FEI: 3014763043 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Signature Orthopaedics Europe Ltd
    Registration Number
    3014763043
    FEI Number
    3014763043
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit A, IDA Business & Technology Park, Garrycastle
    City
    Athlone Westmeath
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K161155

    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, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH

    Proprietary Names

    Origin Coxa Vara Stem Origin Lateral Offset Collared Hip Stem STRATUS Stem Origin Short Neck ENCINA HA Femoral Stem Coxa Vara

    Establishment Types

    Manufacture Medical Device