BEUDAMED
    FDA Registration Active 🇺🇸 United States

    StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit

    Reg #: 3027669735 · FEI: 3027669735 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Bioventus LLC
    Registration Number
    3027669735
    FEI Number
    3027669735
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7101 Goodlett Farms Pkwy
    City
    Cordova
    State
    TN
    ZIP
    38016
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142432

    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 Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device