BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Colorado 2 Spinal System

    Reg #: 1835305 · FEI: 3000203601 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Masterbilt Incorporated
    Registration Number
    1835305
    FEI Number
    3000203601
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3801 Voorde Dr
    City
    South Bend
    State
    IN
    ZIP
    46628
    Country
    US

    Regulatory Submissions

    510(k) Number
    K984360

    Owner / Operator

    Firm Name
    Masterbilt Incorporated
    Operator Number
    10084599
    Address
    3801 Voorde Drive
    City
    South Bend
    State
    IN
    Postal Code
    46628
    Country
    US
    Correspondent
    Rob Michalak

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Interlaminal KWP
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Orthosis, Spinal Pedicle Fixation MNI

    Proprietary Names

    Colorado 2 Spinal System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)