IFUSE IMPLANT SYSTEM
Sacroiliac Joint Fixation
SI-BONE, INC.
The following data is part of a premarket notification filed by Si-bone, Inc. with the FDA for Ifuse Implant System.
Pre-market Notification Details
| Device ID | K122074 |
| 510k Number | K122074 |
| Device Name: | IFUSE IMPLANT SYSTEM |
| Classification | Sacroiliac Joint Fixation |
| Applicant | SI-BONE, INC. 3055 OLIN AVE. SUITE 2200 San Jose, CA 95128 |
| Contact | Cindy Domecus |
| Correspondent | Cindy Domecus SI-BONE, INC. 3055 OLIN AVE. 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 | 2012-07-16 |
| Decision Date | 2012-10-12 |
| Summary: | summary |
Trademark Results [IFUSE IMPLANT SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IFUSE IMPLANT SYSTEM 77799568 3881099 Live/Registered |
SI-BONE, Inc. 2009-08-07 |
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