BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DEXA SOLO-L Standalone Anterior Fusion System

    Reg #: 3010326971 · FEI: 3010326971 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    AURORA SPINE, INC.
    Registration Number
    3010326971
    FEI Number
    3010326971
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1930 Palomar Point Way, Suite #103
    City
    Carlsbad
    State
    CA
    ZIP
    92008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220610

    Owner / Operator

    Firm Name
    Aurora Spine
    Operator Number
    10045511
    Address
    1930 Palomar Point Way, Ste 103
    City
    Carlsbad
    State
    CA
    Postal Code
    92008
    Country
    US
    Correspondent
    Laszlo Garamszegi

    Products

    Device Name Product Code
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD

    Proprietary Names

    DEXA SOLO-L Standalone Anterior Fusion System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device