510(k) K182524 ยท OLO Orthopedic Stereotaxic Instrument
GALILEO Spine Alignment Monitoring System
| Applicant | MiRus, LLC, Marietta GA, US |
| Decision | Substantially Equivalent, Jun 17, 2019 |
| Received | Sep 13, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182524
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.