BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GSO ACP1 Anterior Cervical Plate System

    Reg #: 3006215390 · FEI: 3006215390 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Unified Spine, LLC
    Registration Number
    3006215390
    FEI Number
    3006215390
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6295 Maxtown Road, Suite #500
    City
    Westerville
    State
    OH
    ZIP
    43082
    Country
    US

    Regulatory Submissions

    510(k) Number
    K110990

    Owner / Operator

    Firm Name
    Unified Spine, LLC
    Operator Number
    10083837
    Address
    6295 Maxtown Road, Suite #500
    City
    Westerville
    State
    OH
    Postal Code
    43082
    Country
    US
    Correspondent
    Scott Smith

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Intervertebral Body KWQ

    Proprietary Names

    GSO ACP1 Anterior Cervical Plate System

    Establishment Types

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