BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CURONIX LLC

    Reg #: 3010676138 · FEI: 3010676138 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    6
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    CURONIX LLC
    Registration Number
    3010676138
    FEI Number
    3010676138
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1310 Park Central Boulevard S
    City
    Pompano Beach
    State
    FL
    ZIP
    33064
    Country
    US

    Regulatory Submissions

    510(k) Number
    K150517

    Owner / Operator

    Firm Name
    Curonix LLC
    Operator Number
    10087444
    Address
    1310 Park Central Blvd S
    City
    Pompano Beach
    State
    FL
    Postal Code
    33064
    Country
    US
    Correspondent
    Jessica Coelho

    Products

    Device Name Product Code
    Stimulator, Spinal-Cord, Implanted (Pain Relief) GZB
    Stimulator, Peripheral Nerve, Implanted (Pain Relief) GZF

    Proprietary Names

    Freedom Spinal Cord Stimulator (SCS) System Freedom Peripheral Nerve Stimulator (PNS) System Spinal Cord Stimulator (SCS) SandShark Injectable Anchor (SIA) Accessory Full-Body Freedom PNS System: External Transmitter & Two-Component Neurostimulator with Electrode Array and Receiver Freedom SCS System: External Transmitter and Two Component Implanted Neurostimulator with Electrode Array and Receiver Freedom PNS System: External Transmitter and Two Component Implanted Neurostimulator with Electrode Array and Receiver

    Establishment Types

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