BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ION 3D

    Reg #: 3012495575 · FEI: 3012495575 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    SURGENTEC LLC
    Registration Number
    3012495575
    FEI Number
    3012495575
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    911 Clint Moore Rd
    City
    Boca Raton
    State
    FL
    ZIP
    33487
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243265

    Owner / Operator

    Firm Name
    SurGenTec LLC
    Operator Number
    10055452
    Address
    911 Clint Moore Rd
    City
    Boca Raton
    State
    FL
    Postal Code
    33487
    Country
    US
    Correspondent
    Travis Greenhalgh

    Products

    Device Name Product Code
    Rasp HTR
    Syringe, Piston FMF
    System, Facet Screw Spinal Device MRW

    Proprietary Names

    ION 3D

    Establishment Types

    Manufacture Medical Device