BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Arcos Modular Hip System

    Reg #: 3004153896 · FEI: 3004153896 · Expires 2025
    View on FDA
    Products
    9
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    9

    Registration Details

    Registration Name
    DONSON MACHINE COMPANY
    Registration Number
    3004153896
    FEI Number
    3004153896
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12416 S KEDVALE AVE
    City
    ALSIP
    State
    IL
    ZIP
    60803
    Country
    US

    Regulatory Submissions

    510(k) Number
    K100469

    Owner / Operator

    Firm Name
    DONSON MACHINE COMPANY
    Operator Number
    9057685
    Address
    12416 S KEDVALE AVE, --
    City
    Alsip
    State
    IL
    Postal Code
    60803
    Country
    US
    Correspondent
    JOSEPH - BETTINARDI

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA
    Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) JDL
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI

    Proprietary Names

    Arcos Modular Hip System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)