BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Pathfinder NXT (Pedical Screw System)

    Reg #: 3010009693 · FEI: 3010009693 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    rms Surgical
    Registration Number
    3010009693
    FEI Number
    3010009693
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1220 Lund Blvd
    City
    Anoka
    State
    MN
    ZIP
    55303
    Country
    US

    Regulatory Submissions

    510(k) Number
    K132884

    Owner / Operator

    Firm Name
    THE CRETEX COMPANIES, INC.
    Operator Number
    9001389
    Address
    311 LOWELL AVE., --
    City
    Elk River
    State
    MN
    Postal Code
    55330
    Country
    US
    Correspondent
    DARREN A KLATT

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI

    Proprietary Names

    Pathfinder NXT (Pedical Screw System)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)