BEUDAMED
    FDA Registration Active 🇺🇸 United States

    E3D-A Interbody System

    Reg #: 3012428435 · FEI: 3012428435 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    EVOLUTION SPINE, LLC
    Registration Number
    3012428435
    FEI Number
    3012428435
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2300 N Haskell Ave
    City
    Dallas
    State
    TX
    ZIP
    75204
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232432

    Owner / Operator

    Firm Name
    Evolution Spine, LLC
    Operator Number
    10051848
    Address
    2300 N Haskell Ave
    City
    Dallas
    State
    TX
    Postal Code
    75204
    Country
    US
    Correspondent
    Ashton Kouzbari

    Products

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

    Proprietary Names

    E3D-A Interbody System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device