BEUDAMED
    FDA Registration Active 🇺🇸 United States

    E3D-A Interbody System

    Reg #: 3016112537 · FEI: 3016112537 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    MAINSTREAM MEDICAL DEVICES
    Registration Number
    3016112537
    FEI Number
    3016112537
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3913 Todd Lane, Suites 304; 112
    City
    Austin
    State
    TX
    ZIP
    78744
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223146

    Owner / Operator

    Firm Name
    Mainstream Medical Devices
    Operator Number
    10061802
    Address
    3913 Todd Lane, Suite 304
    City
    Austin
    State
    TX
    Postal Code
    78744
    Country
    US
    Correspondent
    Dana Wilcox

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Intervertebral Fusion Device With Bone Graft, Thoracic PHM

    Proprietary Names

    E3D-A Interbody System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)