BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SI-BONE, INC.

    Reg #: 3007700286 · FEI: 3007700286 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    89
    Establishment Types
    2
    Classifications
    9

    Registration Details

    Registration Name
    SI-BONE, INC.
    Registration Number
    3007700286
    FEI Number
    3007700286
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    471 El Camino Real, Suite 101
    City
    Santa Clara
    State
    CA
    ZIP
    95050
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222605

    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
    Screw, Fixation, Bone HWC
    Tray, Surgical, Instrument FSM
    Hammer, Surgical FZY
    Thoracolumbosacral Pedicle Screw System NKB
    Bit, Drill HTW
    Orthopedic Manual Surgical Instrument LXH
    Neurosurgical Nerve Locator PDQ

    Proprietary Names

    iFuse TORQ Implant System iFuse Implant System - iFuse Navigation Instrument Set iFuse Implant System SI-BONE iFuse Implant System iFuse Navigation iFuse-TORQ Implant System iGPS Navigation Instruments Accessory Instrument Tray Slotted Mallet Slap Hammer Combo iFuse-3D Implant System iFuse Bedrock Granite Implants iFuse Bedrock Granite Closed Head Implants Cannulated Drill Bit, 4mm Cannulated Drill Bit, 7mm XL Cannulated Drill Bit, 7mm XL Cannulated Drill Bit, 4mm Blunt Pin, 3.2mm XL Blunt Pin  3.2mm Pin Sleeve, 4 mm XL Fixed Parallel Pin Guide S-Pin, Thrd, Ball End, 3mm Pin Sleeve Guide Pin  2mm Blunt Pin, 2mm PPG Fixed Distance Plastic Head 15mm Press Fit Exchange Pin  3.2mm XL Drill Sleeve  4mm Guide Pin  3.2mm XL Pin Sleeve  7mm Adjustable Broach Stop XL Blunt Pin  2mm Guide Pin, 3.2mm Drill Sleeve Assembly Variable Parallel Pin Guide XL Drill Sleeve, 7mm Steinmann Pin, 1.8mm Blunt Pin  2mm Slap Hammer, Combo Fixed Parallel Pin Guide Exchange Pin, 2 mm XL Tray System XL Guide Pin  2mm Exchange Pin, 3.2 mm Variable Parallel Pin Guide, Molded Exchange Pin  2mm Guide Pin, 2 mm XL Pin Sleeve  4mm Pin Sleeve, 7mm Steinmann Pin, 3mm XL Adjustable Parallel Pin Guide Adjustable Parallel Pin Guide Drill Sleeve Assembly, 4mm Adapter, Stealth Pin Guide Instrument Tray Pin, Extension, 1.8mm SI-BONE iFuse Tray XL Guide Pin  3.2mm S-Pin, Thrd, Ball End 1.8mm Pin, Extension 3mm Blunt Pin  3.2mm Cannulated Impactor Threaded Inserter Obturator iFuse INTRA X Mallet 11-Gauge Bone Access Needle Decorticator iFuse INTRA X Instrument Set iFuse INTRA X 8-Gauge Bone Access Needle and Tamp iFuse INTRA Instrument Tray Orientation Guide iFuse INTRA X Assist SI-BONE Neuromonitoring Kit iFuse TORQ TNT Implant System iFuse INTRA Ti Implant System iFuse Bedrock Granite™ Implant System FIXED TRACKER – GOLD ROTATING TRACKER - GREEN ROTATING TRACKER - ORANGE ROTATING TRACKER SET FIXED TRACKER SET ROTATING TRACKER - VIOLET FIXED TRACKER – GREEN FIXED TRACKER – BLUE FIXED TRACKER – PURPLE FIXED TRACKER SCREWDRIVER Universal Pin Guide ROTATING TRACKER - GREY Granite Point Lock Set Screw

    Establishment Types

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