BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EmbedMed

    Reg #: 3038011206 · FEI: 3038011206 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Insight Surgery Nebraska
    Registration Number
    3038011206
    FEI Number
    3038011206
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3D Imaging and Advanced Visualization Unit, 8404 Indian Hills Drive
    City
    Omaha
    State
    NE
    ZIP
    68114
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220366

    Owner / Operator

    Firm Name
    3D LifePrints UK
    Operator Number
    10085716
    Address
    Nuffield Orthopaedic Centre, Old Rd
    City
    Oxford
    State
    Oxfordshire
    Postal Code
    OX3 7LD
    Country
    GB
    Correspondent
    Matt Gailer

    Products

    Device Name Product Code
    Driver, Wire, And Bone Drill, Manual DZJ
    System, Image Processing, Radiological LLZ

    Proprietary Names

    EmbedMed

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)