BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Navigated Pedicle Access Kit

    Reg #: 1123169 · FEI: 1000123143 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    IZI MEDICAL PRODUCTS LLC
    Registration Number
    1123169
    FEI Number
    1000123143
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5 Easter Ct Ste J
    City
    Owings Mills
    State
    MD
    ZIP
    21117
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191012

    Owner / Operator

    Firm Name
    IZI MEDICAL PRODUCTS LLC
    Operator Number
    9005298
    Address
    5 Easter Court, Suite J
    City
    Owings Mills
    State
    MD
    Postal Code
    21117
    Country
    US
    Correspondent
    Qiang - Cao

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO

    Proprietary Names

    Navigated Pedicle Access Kit

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility