IFuse Implant System® - IFuse-3D Implant
Sacroiliac Joint Fixation
SI-BONE, INC.
The following data is part of a premarket notification filed by Si-bone, Inc. with the FDA for Ifuse Implant System® - Ifuse-3d Implant.
Pre-market Notification Details
| Device ID | K162733 |
| 510k Number | K162733 |
| Device Name: | IFuse Implant System® - IFuse-3D Implant |
| Classification | Sacroiliac Joint Fixation |
| Applicant | SI-BONE, INC. 3055 OLIN AVE, SUITE 2200 San Jose, CA 95128 |
| Contact | Roxanne Dubois |
| Correspondent | Roxanne Dubois SI-BONE, INC. 3055 OLIN AVE, SUITE 2200 San Jose, CA 95128 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-29 |
| Decision Date | 2017-03-10 |
| Summary: | summary |
Trademark Results [IFuse Implant System]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IFUSE IMPLANT SYSTEM 77799568 3881099 Live/Registered |
SI-BONE, Inc. 2009-08-07 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.