BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Anato¿ Hip System Instrumentation

    Reg #: 3001284227 · FEI: 3001284227 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    SMITHSTOWN LIGHT ENGINEERING
    Registration Number
    3001284227
    FEI Number
    3001284227
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Bay H1A,, Smithstown Industrial Estate,
    City
    Shannon Clare
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K123604

    Owner / Operator

    Firm Name
    Smithstown Light Engineering
    Operator Number
    10043193
    Address
    Smithstown industrial estate, Smithstown Industrial Estate,
    City
    Shannon
    State
    Clare
    Postal Code
    V14 W594
    Country
    IE

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous MBL
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH

    Proprietary Names

    Anato¿ Hip System Instrumentation

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)