BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Proven Gen-Flex PS Knee Sysytem

    Reg #: 3010468876 · FEI: 3005601732 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    TRIGON INCORPORATED
    Registration Number
    3010468876
    FEI Number
    3005601732
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    124 HIDDEN VALLEY RD
    City
    Mc Murray
    State
    PA
    ZIP
    15317
    Country
    US

    Regulatory Submissions

    510(k) Number
    K970490

    Owner / Operator

    Firm Name
    FPD Company
    Operator Number
    10044979
    Address
    124 Hidden Valley Rd.
    City
    McMurray
    State
    PA
    Postal Code
    15317
    Country
    US
    Correspondent
    Courtney M Harney

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI

    Proprietary Names

    Proven Gen-Flex PS Knee Sysytem

    Establishment Types

    Manufacture Medical Device