Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007700286

FEI Number

3007700286

Entity Name

SI-BONE, INC.

City/State/Country

Santa Clara, CA, US

Establishment Address

471 El Camino Real, Suite 101, Santa Clara, CA 95050, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

SI-BONE, Inc. (Owner Number: 10029402)

Owner / Operator Contact Address

471 El Camino Real, Suite 101, Santa Clara, CA 95050, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241504

PMA Number

N/A

All Registered Proprietary Names

iFuse TORQ Implant System iFuse Implant System - iFuse Navigation Instrument Set iFuse Implant System iFuse Implant System iFuse Implant System SI-BONE iFuse Implant System iFuse Implant System iFuse Navigation iFuse-TORQ Implant System iGPS Navigation Instruments iFuse Implant System iFuse TORQ Implant System Accessory Instrument Tray Slotted Mallet Slap Hammer Combo iFuse Implant System iFuse Implant System 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 iFuse TORQ Implant System iFuse Implant System 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 iFuse TORQ Implant System SI-BONE Neuromonitoring Kit iFuse TORQ TNT Implant System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-10-16
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2023-10-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-10-16
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-10-16
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2023-10-16
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2023-10-16
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2023-10-16
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2023-10-16
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2023-10-16
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2017-11-03
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2021-03-02
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-09-16
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2023-10-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-05
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2025-06-05
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-06-05
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-01-03
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2011-01-25
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2023-10-16
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2018-10-03
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-03-08
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-03-08
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2024-03-08
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2011-01-25
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-10-16
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2023-10-16
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-10-16
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2023-10-16
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2011-01-20
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2023-10-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-10-16
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2016-10-19
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2024-08-29
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-08-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-08-29

Official Correspondent

Daniel Cher

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SI-BONE, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3021948057	SI-BONE, INC.	Santa Clara, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K213667	SI-BONE, Inc.	iFuse-TORQ® Implant System	2022-06-10
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007700286. Last updated year: 2026. Please use registration number 3007700286 when referencing this establishment in official correspondence.