510(k) K192495 ยท OLO Orthopedic Stereotaxic Instrument
Black Diamond Navigation Instruments
| Applicant | Osseus Fusion Systems, Dallas TX, US |
| Decision | Substantially Equivalent, Jan 17, 2020 |
| Received | Sep 11, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192495
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.