Data / Medical devices / United States / Si-Bone, Inc.
Si-Bone, Inc.: FDA-registered device maker in Santa Clara, CA, United States, 29 510(k) clearances
Si-Bone, Inc. is registered with the FDA (registration 3007700286) in Santa Clara, CA, United States. It lists 9 device types. The FDA files 29 510(k) clearances under its listings, the newest dated September 23, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007700286
- Address
- 471 El Camino Real, Suite 101, Santa Clara, CA, United States, 95050
- Owner or operator
- SI-BONE, Inc. (10029402)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- January 20, 2011
- Registered through
- 2026
- Brand names listed
- 11-Gauge Bone Access Needle, Accessory Instrument Tray, Adapter, Stealth Pin Guide, Adjustable Broach Stop, Adjustable Parallel Pin Guide, Blunt Pin 2mm, Blunt Pin 3.2mm, Blunt Pin, 2mm and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Neurosurgical Nerve Locator | PDQ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Sacroiliac Joint Fixation | OUR | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 23, 2026 | K262067 | iFuse Granite Onyx Implant System | NKB | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| February 11, 2026 | K253488 | iFuse INTRA Ti Implant System | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| October 9, 2025 | K253094 | iFuse Bedrock Granite Implant System | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| September 15, 2025 | K251780 | iGPS Navigation Instruments | OLO | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| August 19, 2024 | K241504 | iFuse TORQ TNT Implant System | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| July 2, 2024 | K241574 | iFuse TORQ® Implant System | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| February 23, 2024 | K232800 | Navigation Tracking Instruments | OLO | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| January 26, 2024 | K233508 | iFuse Bedrock Granite® Implant System | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| June 30, 2023 | K231689 | iFuse TORQ® Implant System | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| December 22, 2022 | K222774 | iFuse Bedrock Granite® Implant System | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| September 29, 2022 | K222605 | iFuse TORQ® Implant System | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| June 10, 2022 | K213667 | iFuse-TORQ® Implant System | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| May 26, 2022 | K220195 | iFuse Bedrock Granite Implant System | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| February 25, 2021 | K203247 | iFuse-TORQ Implant System | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| November 9, 2020 | K203110 | iFuse Implant System - iFuse Navigation | OLO | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| March 31, 2020 | K193524 | SI-BONE iFuse Implant System® | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| April 3, 2019 | K190230 | iFuse Implant System® | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| November 27, 2018 | K182983 | iFuse Implant System® | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| October 31, 2017 | K172268 | iFuse Implant System- iFuse Navigation | OLO | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| March 10, 2017 | K162733 | iFuse Implant System® - iFuse-3D implant | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| October 18, 2016 | K161893 | Neuromonitoring Kit | PDQ | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| June 3, 2016 | K160652 | iFUSE Implant System | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| March 1, 2016 | K152681 | iFuse Implant System(R) | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| October 29, 2015 | K151718 | iFuse Implant System | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| July 22, 2015 | K150875 | iFuse Implant System | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| April 17, 2015 | K150714 | SI-BONE iFuse Implant System | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| July 23, 2014 | K141049 | IFUSE IMPLANT SYSTEM | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| April 1, 2013 | K123850 | IFUSE IMPLANT SYSTEM | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| October 12, 2012 | K122074 | IFUSE IMPLANT SYSTEM | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 21, 2026 | 99868 | Class II | Ongoing | iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm) | The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured. | accessdata.fda.gov |
Compare with other makers
- All makers of Sacroiliac Joint Fixation
- All makers of Orthopedic Stereotaxic Instrument
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Neurosurgical Nerve Locator
- All makers of Screw, Fixation, Bone
- All makers of Tray, Surgical, Instrument
Updated October 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.