BEUDAMED
    FDA Registration Active 🇺🇸 United States

    iFuse TORQ Implant System

    Reg #: 3007700286 · FEI: 3007700286 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    SI-BONE, INC.
    Registration Number
    3007700286
    FEI Number
    3007700286
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    471 El Camino Real, Suite 101
    City
    Santa Clara
    State
    CA
    ZIP
    95050
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222774

    Owner / Operator

    Firm Name
    SI-BONE, Inc.
    Operator Number
    10029402
    Address
    471 El Camino Real, Suite 101
    City
    Santa Clara
    State
    CA
    Postal Code
    95050
    Country
    US
    Correspondent
    Daniel Cher

    Products

    Device Name Product Code
    Orthopedic Stereotaxic Instrument OLO
    Sacroiliac Joint Fixation OUR
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    iFuse TORQ Implant System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198