BEUDAMED
    FDA Registration Active 🇺🇸 United States

    XL Blunt Pin  2mm

    Reg #: 3007700286 · FEI: 3007700286 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    55
    Establishment Types
    2
    Classifications
    1

    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

    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 Manual Surgical Instrument LXH

    Proprietary Names

    XL Blunt Pin  2mm Variable Parallel Pin Guide, Molded XL Pin Sleeve  4mm Blunt Pin  3.2mm Adapter, Stealth Pin Guide Adjustable Broach Stop Pin, Extension 3mm PPG Fixed Distance Plastic Head 15mm Press Fit XL Guide Pin  3.2mm Exchange Pin  3.2mm XL Adjustable Parallel Pin Guide Pin Sleeve XL Tray System XL Blunt Pin  3.2mm Drill Sleeve Assembly Adjustable Parallel Pin Guide Variable Parallel Pin Guide Pin Sleeve, 4 mm Instrument Tray Blunt Pin, 2mm XL Fixed Parallel Pin Guide Guide Pin  2mm Exchange Pin  2mm Slap Hammer, Combo Blunt Pin, 3.2mm Guide Pin, 3.2mm Pin, Extension, 1.8mm SI-BONE iFuse Tray XL Drill Sleeve, 7mm Blunt Pin  2mm Guide Pin, 2 mm S-Pin, Thrd, Ball End, 3mm Fixed Parallel Pin Guide Exchange Pin, 2 mm XL Pin Sleeve  7mm Steinmann Pin, 1.8mm Pin Sleeve, 7mm Guide Pin  3.2mm XL Drill Sleeve  4mm Steinmann Pin, 3mm S-Pin, Thrd, Ball End 1.8mm XL Guide Pin  2mm Drill Sleeve Assembly, 4mm Exchange Pin, 3.2 mm Cannulated Impactor Threaded Inserter iFuse INTRA X Mallet iFuse INTRA X 8-Gauge Bone Access Needle and Tamp iFuse INTRA Instrument Tray Obturator 11-Gauge Bone Access Needle Decorticator Orientation Guide iFuse INTRA X Instrument Set iFuse INTRA X Assist

    Establishment Types

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