SI-BONE, Inc.
FDA 510(k) & PMA Approved Devices — 22 products
Total Devices22
Categories3
Latest FDA decision2026-02-11
SEC Filings: 1 filings on record. Latest: 8-K (2026-08-03). View on SEC EDGAR →
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K253488 | iFuse INTRA Ti™ Implant System | OUR | 2026-02-11 | View |
| 510(k) | K253094 | iFuse Bedrock Granite Implant System | OUR | 2025-10-09 | View |
| 510(k) | K251780 | iGPS Navigation Instruments | OLO | 2025-09-15 | View |
| 510(k) | K241504 | iFuse TORQ TNT™ Implant System | OUR | 2024-08-19 | View |
| 510(k) | K241574 | iFuse TORQ® Implant System | OUR | 2024-07-02 | View |
| 510(k) | K232800 | Navigation Tracking Instruments | OLO | 2024-02-23 | View |
| 510(k) | K233508 | iFuse Bedrock Granite® Implant System | OUR | 2024-01-26 | View |
| 510(k) | K231689 | iFuse TORQ® Implant System | OUR | 2023-06-30 | View |
| 510(k) | K222774 | iFuse Bedrock Granite® Implant System | OUR | 2022-12-22 | View |
| 510(k) | K222605 | iFuse TORQ® Implant System | OUR | 2022-09-29 | View |
| 510(k) | K213667 | iFuse-TORQ® Implant System | OUR | 2022-06-10 | View |
| 510(k) | K220195 | iFuse Bedrock Granite™ Implant System | OUR | 2022-05-26 | View |
| 510(k) | K203247 | iFuse-TORQ™ Implant System | OUR | 2021-02-25 | View |
| 510(k) | K203110 | iFuse Implant System - iFuse Navigation | OLO | 2020-11-09 | View |
| 510(k) | K193524 | SI-BONE iFuse Implant System® | OUR | 2020-03-31 | View |
| 510(k) | K190230 | iFuse Implant System® | OUR | 2019-04-03 | View |
| 510(k) | K182983 | iFuse Implant System® | OUR | 2018-11-27 | View |
| 510(k) | K172268 | iFuse Implant System- iFuse Navigation | OLO | 2017-10-31 | View |
| 510(k) | K162733 | iFuse Implant System® - iFuse-3D implant | OUR | 2017-03-10 | View |
| 510(k) | K161893 | Neuromonitoring Kit | PDQ | 2016-10-18 | View |
No matching devices.
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Related Clinical Trials
NCT05870488iFuse TORQ for the Treatment of Sacroiliac Joint DysfunctionACTIVE_NOT_RECRUITINGNCT07530497Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring FracturesRECRUITINGNCT07565545Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness OutcomesNOT_YET_RECRUITING