BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    AltiVate Anatomic, Humeral Broach, 16mm

    Reg #: 3009141957 · FEI: 3009141957 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Paragon Medical Siechnice
    Registration Number
    3009141957
    FEI Number
    3009141957
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Stanislawa Staszica 5
    City
    Siechnice Dolnoslaskie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K162024

    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

    US Agent

    Business Name
    Paragon Medical
    Contact Name
    Stephane Langlois
    Address
    8 Matchett Dr
    City
    Pierceton
    State
    IN
    ZIP
    46562
    Country
    US
    Email
    [email protected]
    Phone
    435 5355456

    Products

    Device Name Product Code
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS

    Proprietary Names

    AltiVate Anatomic, Humeral Broach, 16mm AltiVate Anatomic, Humeral Broach, 14mm AltiVate Anatomic, Humeral Broach, 18mm AltiVate Anatomic, Humeral Broach, 8mm AltiVate Anatomic, Humeral Broach, 12mm AltiVate Anatomic, Humeral Broach, 10mm

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)