BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EUROPA™ Pedicle Screw System

    Reg #: 3014655115 · FEI: 3014655115 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    MIRUS, LLC
    Registration Number
    3014655115
    FEI Number
    3014655115
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1755 W Oak Parkway, Suite 100
    City
    Marietta
    State
    GA
    ZIP
    30062
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180337

    Owner / Operator

    Firm Name
    MiRus, LLC
    Operator Number
    10059692
    Address
    1755 West Oak Parkway, Suite 100
    City
    Marietta
    State
    GA
    Postal Code
    30062
    Country
    US
    Correspondent
    Jordan Bauman

    Products

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

    Proprietary Names

    EUROPA™ Pedicle Screw System

    Establishment Types

    Manufacture Medical Device