BEUDAMED
    FDA Registration Active 🇫🇷 France

    Needle XS

    Reg #: 3008102049 · FEI: 3008102049 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SPINEGUARD, SA
    Registration Number
    3008102049
    FEI Number
    3008102049
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10, Cours Louis Lumiere
    City
    Vincennes Paris
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K241895

    Owner / Operator

    Firm Name
    SpineGuard, SA
    Operator Number
    10031002
    Address
    10, cours Louis LUMIERE
    City
    Vincennes
    State
    Paris
    Postal Code
    94300
    Country
    FR
    Correspondent
    Stephane Bette

    US Agent

    Business Name
    SpineGuard, Inc.
    Contact Name
    Stephane Bette
    Address
    1434 Spruce Street, Suite 100
    City
    Boulder
    State
    CO
    ZIP
    80302
    Country
    US
    Email
    [email protected]
    Phone
    303 9177737

    Products

    Device Name Product Code
    Sacroiliac Joint Guidewire Placement Device SCY

    Proprietary Names

    Needle XS DSG Handle DSG Connect Handle Cannulated PsiFGuard

    Establishment Types

    Manufacture Medical Device