BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GUARDIAN MEDICAL USA, INC

    Reg #: 3016261131 · FEI: 3016261131 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    GUARDIAN MEDICAL USA, INC
    Registration Number
    3016261131
    FEI Number
    3016261131
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11360 S Airfield Rd
    City
    Swanton
    State
    OH
    ZIP
    43558
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162750

    Owner / Operator

    Firm Name
    Guardian Medical USA, LLC
    Operator Number
    10062293
    Address
    11360 S Airfield Rd
    City
    Swanton
    State
    OH
    Postal Code
    43558
    Country
    US
    Correspondent
    Tracy Momany

    Products

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

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)