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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810116510160 | K220115 | 000 |
| 00810116510016 | K220115 | 000 |
| 00810116510023 | K220115 | 000 |
| 00810116510030 | K220115 | 000 |
| 00810116510047 | K220115 | 000 |
| 00810116510054 | K220115 | 000 |
| 00810116510061 | K220115 | 000 |
| 00810116510078 | K220115 | 000 |
| 00810116510085 | K220115 | 000 |
| 00810116510092 | K220115 | 000 |
| 00810116510108 | K220115 | 000 |
| 00810116510115 | K220115 | 000 |
| 00810116510122 | K220115 | 000 |
| 00810116510139 | K220115 | 000 |
| 00810116510146 | K220115 | 000 |
| 00810116510153 | K220115 | 000 |
| 00810116510009 | K220115 | 000 |