BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TriALTIS Spine System

    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
    K231479

    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
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    TriALTIS Spine System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)