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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239800633 | K203373 | 000 |
| 00840239800084 | K203373 | 000 |
| 00840239800091 | K203373 | 000 |
| 00840239800107 | K203373 | 000 |
| 00840239800114 | K203373 | 000 |
| 00840239800121 | K203373 | 000 |
| 00840239800138 | K203373 | 000 |
| 00840239800145 | K203373 | 000 |
| 00840239800152 | K203373 | 000 |
| 00840239800077 | K203373 | 000 |
| 00840239800060 | K203373 | 000 |
| 00840239800442 | K203373 | 000 |
| 00840239800381 | K203373 | 000 |
| 00840239800374 | K203373 | 000 |
| 00840239800015 | K203373 | 000 |
| 00840239800022 | K203373 | 000 |
| 00840239800039 | K203373 | 000 |
| 00840239800046 | K203373 | 000 |
| 00840239800053 | K203373 | 000 |
| 00840239800169 | K203373 | 000 |
| 00840239800176 | K203373 | 000 |
| 00840239800183 | K203373 | 000 |
| 00840239800305 | K203373 | 000 |
| 00840239800312 | K203373 | 000 |
| 00840239800329 | K203373 | 000 |
| 00840239800336 | K203373 | 000 |
| 00840239800343 | K203373 | 000 |
| 00840239800350 | K203373 | 000 |
| 00840239800367 | K203373 | 000 |
| 00840239800008 | K203373 | 000 |
| 00840239800299 | K203373 | 000 |
| 00840239800282 | K203373 | 000 |
| 00840239800190 | K203373 | 000 |
| 00840239800206 | K203373 | 000 |
| 00840239800220 | K203373 | 000 |
| 00840239800237 | K203373 | 000 |
| 00840239800244 | K203373 | 000 |
| 00840239800251 | K203373 | 000 |
| 00840239800268 | K203373 | 000 |
| 00840239800275 | K203373 | 000 |
| 00840239800213 | K203373 | 000 |