The following data is part of a premarket notification filed by Si-bone, Inc. with the FDA for Ifuse Implant System- Ifuse Navigation.
| Device ID | K172268 |
| 510k Number | K172268 |
| Device Name: | IFuse Implant System- IFuse Navigation |
| Classification | Orthopedic Stereotaxic Instrument |
| 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 | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-27 |
| Decision Date | 2017-10-31 |
| Summary: | summary |