510(k) K180523 ยท OLO Orthopedic Stereotaxic Instrument
INTAI Surgery Navigation System
| Applicant | Intai Technology Corporation, Taichung, TW |
| Decision | Substantially Equivalent, Sep 20, 2019 |
| Received | Feb 27, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180523
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.