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 |