The following data is part of a premarket notification filed by Mirus, Llc with the FDA for Galileo Spine Alignment Monitoring System.
| Device ID | K182524 |
| 510k Number | K182524 |
| Device Name: | GALILEO Spine Alignment Monitoring System |
| Classification | Orthopedic Stereotaxic Instrument |
| 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 | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-13 |
| Decision Date | 2019-06-17 |