510(k) K172115 ยท OLO Orthopedic Stereotaxic Instrument
Navigated Instrument System
| Applicant | Orthofix, Inc., Lewisville TX, US |
| Decision | Substantially Equivalent, Mar 8, 2018 |
| Received | Jul 13, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K172115
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.