The following data is part of a premarket notification filed by Mirus, Llc with the FDA for Atlas Plating System.
| Device ID | K191867 |
| 510k Number | K191867 |
| Device Name: | ATLAS Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | MiRus, LLC 2150 Newmarket Parkway, Suite 108 Marietta, GA 30067 |
| Contact | Jordan Bauman |
| Correspondent | Jordan Bauman MiRus, LLC 2150 Newmarket Parkway, Suite 108 Marietta, GA 30067 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-12 |
| Decision Date | 2020-04-09 |