The following data is part of a premarket notification filed by Mirus, Llc with the FDA for Antares 3dr Standalone Anterior Lumbar Interbody Fusion System.
| Device ID | K220115 |
| 510k Number | K220115 |
| Device Name: | ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | MiRus, LLC 1755 West Oak Parkway, Suite 100 Marietta, GA 30062 |
| Contact | Jordan Bauman |
| Correspondent | Jordan Bauman MiRus, LLC 1755 West Oak Parkway, Suite 100 Marietta, GA 30062 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-14 |
| Decision Date | 2022-05-13 |