BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Comprehensive Revision Broach/Provisional 8mm

    Reg #: 1834331 · FEI: 1000306340 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    4

    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
    K060692

    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, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS

    Proprietary Names

    Comprehensive Revision Broach/Provisional 8mm Comprehensive Revision Broach/Provisional 12mm Comprehensive Revision Broach/Provisional 4mm Comprehensive Revision Broach/Provisional 14mm Comprehensive Revision Broach/Provisional 10mm Comprehensive Revision Broach/Provisional 6mm Comprehensive Shoulder System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)