BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Comprehensive Shoulder System

    Reg #: 3009973844 · FEI: 3009973844 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Kyocera SGS Precision Tools
    Registration Number
    3009973844
    FEI Number
    3009973844
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    201 S Towerview Dr
    City
    Columbia City
    State
    IN
    ZIP
    46725
    Country
    US

    Regulatory Submissions

    510(k) Number
    K060694

    Owner / Operator

    Firm Name
    Kyocera SGS Precision Tools - Medical Division
    Operator Number
    10042633
    Address
    201 S.Towerview Drive
    City
    Columbia City
    State
    IN
    Postal Code
    46725
    Country
    US
    Correspondent
    Anthony A Lozano

    Products

    Device Name Product Code
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT

    Proprietary Names

    Comprehensive Shoulder System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)