SI-BONE, INC.

FDA Device Registration & Listing · Santa Clara, CA, US · Registration 3021948057

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3021948057
FEI Number
3021948057
Entity Name
SI-BONE, INC.
City/State/Country
Santa Clara, CA, US
Establishment Address
2380 Owen St., Santa Clara, CA 95054, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
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
N
Expiration Date (Year)
2026
510(k) Number
K233508
PMA Number
N/A

All Registered Proprietary Names

iFuse TORQ Implant System iFuse-TORQ 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 iFuse Implant System iFuse Implant System iFuse Implant System SI-BONE Neuromonitoring Kit iFuse TORQ Implant System Slotted Mallet Slap Hammer Combo iFuse Implant System iFuse TORQ TNT Implant System FZX, Guide, Surgical, Instrument SI-BONE iFuse Implant System iGPS Navigation Instruments 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 Implant System iFuse Implant System iFuse Implant System - iFuse Navigation Instrument Set iFuse INTRA Ti Implant System iFuse TORQ Implant System Granite Point Lock Set Screw iFuse Implant System (SI Joint Fusion System) SI-BONE iFuse Implant System iFuse Implant System iFuse-3D Implant System iFuse TORQ Implant System iFuse Bedrock Granite Implants iFuse Bedrock Granite Closed Head Implants

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
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-10-16
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2021-03-02
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2022-05-26
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-05-26
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-05-26
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-03-08
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2014-03-07
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2023-10-16
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2023-10-16
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2016-10-19
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
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 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
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2011-01-25
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2023-10-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-09-16
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
OUR Sacroiliac Joint Fixation 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 2026-02-12
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
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2025-11-21
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-11-21
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-11-21
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2009-12-31
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2023-10-16
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2018-10-03
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 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

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
3007700286 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
K163363 Surgtech, Inc. SurgTech Thoracolumbosacral (TLS) Posterior Fixation System 2017-04-05
K252461 Spinal Resources, Inc. Swedge™ Pedicle Screw Fixation System Bezier Rod 2026-01-13
K140696 Pioneer Surgical Technology, Inc. STREAMLINE TL SPINAL FIXATION SYSTEM 2014-04-10

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-0001-2013 Synthes USA HQ, Inc. 2
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.

Similar Registrations

Registration Number Establishment Name Location
3002743211 NORTHERN DIGITAL, INC. WATERLOO Ontario, CA
3016050940 Olive Branch Distribution Center Olive Branch, MS, US
3020983478 ORTHOKEY ITALIA SRL Firenze, IT
3014725904 Medtronic Medical Costa Rica S.R.L. Coyol Alajuela, CR
3018405359 A7 INTEGRATION Granby Quebec, CA
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021948057. Last updated year: 2026. Please use registration number 3021948057 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.