The following data is part of a premarket notification filed by Si-bone, Inc. with the FDA for Modification To Si Joint Fusion System.
| Device ID | K092375 |
| 510k Number | K092375 |
| Device Name: | MODIFICATION TO SI JOINT FUSION SYSTEM |
| Classification | Sacroiliac Joint Fixation |
| Applicant | SI-BONE, INC. 555 THIRTEENTH ST., NW Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein SI-BONE, INC. 555 THIRTEENTH ST., NW Washington, DC 20004 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-05 |
| Decision Date | 2009-09-04 |
| Summary: | summary |