BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Mendell

    Reg #: 3009998573 · FEI: 3009998573 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Mendell
    Registration Number
    3009998573
    FEI Number
    3009998573
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    21463 Grenada Ave
    City
    Lakeville
    State
    MN
    ZIP
    55044
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120399

    Owner / Operator

    Firm Name
    Mendell Machine and Manufacturing, LLC
    Operator Number
    10042591
    Address
    21463 Grenada Avenue
    City
    Lakeville
    State
    MN
    Postal Code
    55044
    Country
    US
    Correspondent
    Susan Mayer

    Products

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

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)