BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TRABECULAR METAL REVISION SHELL LINERS

    Reg #: 1834331 · FEI: 1000306340 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PARAGON MEDICAL, INC.
    Registration Number
    1834331
    FEI Number
    1000306340
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8 Matchett Dr.
    City
    PIERCETON
    State
    IN
    ZIP
    46562
    Country
    US

    Regulatory Submissions

    510(k) Number
    K051516

    Owner / Operator

    Firm Name
    Paragon Medical
    Operator Number
    9011072
    Address
    8 Matchett Dr., --
    City
    Pierceton
    State
    IN
    Postal Code
    46562
    Country
    US
    Correspondent
    Stephane Langlois

    Products

    Device Name Product Code
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI

    Proprietary Names

    TRABECULAR METAL REVISION SHELL LINERS

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)