Data / Medical devices / United States / Si-Bone, Inc.
Si-Bone, Inc.: FDA-registered device maker in Santa Clara, CA, United States, 33 510(k) clearances
Si-Bone, Inc. is registered with the FDA (registration 3021948057) in Santa Clara, CA, United States. It lists 11 device types. The FDA files 33 510(k) clearances under its listings, the newest dated September 23, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021948057
- Address
- 2380 Owen St., Santa Clara, CA, United States, 95054
- Owner or operator
- SI-BONE, Inc. (10029402)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- May 11, 2009
- 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 | Manufacturer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Manufacturer | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Manufacturer | accessdata.fda.gov |
| Knife, Orthopedic | HTS | 1 | Manufacturer | accessdata.fda.gov |
| Neurosurgical Nerve Locator | PDQ | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Sacroiliac Joint Fixation | OUR | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Manufacturer, 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 |
| October 16, 2013 | K131405 | 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 |
| April 21, 2011 | K110838 | IFUSE IMPLANT SYSTEM | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| September 4, 2009 | K092375 | MODIFICATION TO SI JOINT FUSION SYSTEM | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
| November 26, 2008 | K080398 | SI JOINT FUSION SYSTEM | OUR | Substantially Equivalent | SI-BONE, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Knife, Orthopedic
- All makers of Screw, Fixation, Bone
- All makers of Sacroiliac Joint Fixation
- All makers of Orthopedic Stereotaxic Instrument
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Tray, Surgical, Instrument
Updated September 23, 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.