The following data is part of a premarket notification filed by Si-bone, Inc with the FDA for Si-bone Ifuse Implant System®.
| Device ID | K193524 |
| 510k Number | K193524 |
| Device Name: | SI-BONE IFuse Implant System® |
| Classification | Sacroiliac Joint Fixation |
| Applicant | Si-Bone, Inc 47 El Camino Real, Suite 101 Santa Clara, CA 95050 |
| Contact | Susan Noriega |
| Correspondent | Susan Noriega Si-Bone, Inc 47 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 | 2019-12-19 |
| Decision Date | 2020-03-31 |
| Summary: | summary |