The following data is part of a premarket notification filed by Advanced Research Medical, Llc with the FDA for Advanced Research Medical Trident Si Screw System.
| Device ID | K203373 |
| 510k Number | K203373 |
| Device Name: | Advanced Research Medical Trident SI Screw System |
| Classification | Sacroiliac Joint Fixation |
| Applicant | Advanced Research Medical, LLC 1515 Hwy 13 East Burnsville, MN 55337 |
| Contact | John D. Siegel |
| Correspondent | Kyle Kovach JALEX Medical 27865 Clemens Rd., Suite #3 Westlake, OH 44145 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-16 |
| Decision Date | 2021-01-22 |