The following data is part of a premarket notification filed by Si-bone, Inc. with the FDA for Ifuse-torq® Implant System.
| Device ID | K213667 |
| 510k Number | K213667 |
| Device Name: | IFuse-TORQ® Implant System |
| Classification | Sacroiliac Joint Fixation |
| Applicant | SI-BONE, Inc. 471 El Camino Real, Suite 101 Santa Clara, CA 95050 |
| Contact | Meirav Harsat |
| Correspondent | Meirav Harsat SI-BONE, Inc. 471 El Camino Real, Suite 101 Santa Clara, CA 95050 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-22 |
| Decision Date | 2022-06-10 |