510(k) K181449 ยท OLO Orthopedic Stereotaxic Instrument
Ortoma Treatment Solution - OTS
| Applicant | Ortoma AB, Goteborg, SE |
| Decision | Substantially Equivalent, Sep 19, 2018 |
| Received | Jun 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181449
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.