The following data is part of a premarket notification filed by Si-bone, Inc. with the FDA for Ifuse Implant System(r).
| Device ID | K152681 |
| 510k Number | K152681 |
| Device Name: | IFuse Implant System(R) |
| Classification | Sacroiliac Joint Fixation |
| Applicant | SI-BONE, INC. 3055 OLIN AVENUE, SUITE 2200 San Jose, CA 95128 |
| Contact | Roxanne Dubois |
| Correspondent | Roxanne Dubois SI-BONE, INC. 3055 OLIN AVENUE, 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 | 2015-09-18 |
| Decision Date | 2016-03-01 |
| Summary: | summary |