The following data is part of a premarket notification filed by Sij Surgical with the FDA for Outlet Sacroiliac Joint Fusion System.
| Device ID | K181881 |
| 510k Number | K181881 |
| Device Name: | Outlet Sacroiliac Joint Fusion System |
| Classification | Sacroiliac Joint Fixation |
| Applicant | SIJ Surgical 6829 Falls Of Neuse Rd., Ste 103 Raleigh, NC 27615 |
| Contact | Daniel Hoehn |
| Correspondent | Meredith L. May Empirical Consulting, LLC 4628 Northpark Dr Colorado Springs, CO 80918 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-13 |
| Decision Date | 2018-10-03 |
| Summary: | summary |