510(k) K191012 ยท OLO Orthopedic Stereotaxic Instrument
Navigated Pedicle Access Kit
| Applicant | Izi Medical Products, LLC, Owings Mills MD, US |
| Decision | Substantially Equivalent, Aug 7, 2019 |
| Received | Apr 16, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191012
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.