| K-number | K150875 |
| Device name | iFuse Implant System |
| Applicant | SI-BONE, Inc. |
| Product code | OUR |
| Device class | Class II |
| Decision date | Jul 22, 2015 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov