The following data is part of a premarket notification filed by Biofusion Medical with the FDA for Si-restore Sacroiliac Joint Fixation System.
| Device ID | K200868 |
| 510k Number | K200868 |
| Device Name: | SI-Restore Sacroiliac Joint Fixation System |
| Classification | Sacroiliac Joint Fixation |
| Applicant | Biofusion Medical 2101 E St Elmo Rd, Building 1, Suite 100, PMB-1, Office 231 Austin, TX 74744 |
| Contact | Rylan Reed |
| Correspondent | Daniel Lanois SurgOp Support 101 Lamond Ct Prosper, TX 75078 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-01 |
| Decision Date | 2020-04-17 |