BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Polyaxial Screwdriver

    Reg #: 2134470 · FEI: 3002462840 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    LOWELL,INC.
    Registration Number
    2134470
    FEI Number
    3002462840
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9425 83RD AVE. N.
    City
    Brooklyn Park
    State
    MN
    ZIP
    55445
    Country
    US

    Regulatory Submissions

    510(k) Number
    K062670

    Owner / Operator

    Firm Name
    Lowell Inc.
    Operator Number
    9034888
    Address
    9425 83RD AVE. N., --
    City
    Minneapolis
    State
    MN
    Postal Code
    55445
    Country
    US
    Correspondent
    Jack - Wieland

    Products

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

    Proprietary Names

    Polyaxial Screwdriver

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)