BEUDAMED
    FDA Registration Active 🇺🇸 United States

    StimRouter Neuromodulation System

    Reg #: 3009595577 · FEI: 3009595577 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BIOVENTUS LLC
    Registration Number
    3009595577
    FEI Number
    3009595577
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4721 Emperor Blvd Ste 100
    City
    Durham
    State
    NC
    ZIP
    27703
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190047

    Owner / Operator

    Firm Name
    Bioventus LLC
    Operator Number
    10040666
    Address
    4721 Emperor Blvd., Suite 100
    City
    Durham
    State
    NC
    Postal Code
    27703
    Country
    US
    Correspondent
    Kellie Stefaniak

    Products

    Device Name Product Code
    Stimulator, Peripheral Nerve, Implanted (Pain Relief) GZF

    Proprietary Names

    StimRouter Neuromodulation System

    Establishment Types

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