BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EmbedMed

    Reg #: 3027329005 · FEI: 3027329005 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Insight Surgery Houston
    Registration Number
    3027329005
    FEI Number
    3027329005
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    TMC Innovation, 2450 Holcombe Blvd, Suite 1820
    City
    Houston
    State
    TX
    ZIP
    77021
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221943

    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
    System, Image Processing, Radiological LLZ
    Orthopaedic Surgical Planning And Instrument Guides PBF

    Proprietary Names

    EmbedMed

    Establishment Types

    Manufacture Medical Device