IFuse Implant System®
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®.
Pre-market Notification Details
| Device ID | K190230 |
| 510k Number | K190230 |
| Device Name: | IFuse Implant System® |
| Classification | Sacroiliac Joint Fixation |
| Applicant | SI-BONE, Inc. 471 El Camino Real, Suite 101 Santa Clara, CA 95050 |
| Contact | Meirav Harsat |
| Correspondent | Cindy Domecus Domecus Consulting Services LLC 1171 Barroihet Drive Hillsborough, CA 94010 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-06 |
| Decision Date | 2019-04-03 |
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 |
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