510(k) K163471 · PEK Spinous Process Plate
Kalitec Direct InSePtion MIS Fixation System
| Applicant | Kalitec Direct, LLC, Orlando FL, US |
| Decision | Substantially Equivalent, Mar 16, 2017 |
| Received | Dec 12, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163471
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.