510(k) K180271 · OLO Orthopedic Stereotaxic Instrument
NAVIO Surgical System (NAVIO system)
| Applicant | Blue Belt Technologies, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Apr 6, 2018 |
| Received | Jan 31, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180271
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.