510(k) K132765 ยท PEK Spinous Process Plate
PFX SPINOUS PROCESS FIXATION SYSTEM
| Applicant | Innovasis, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jul 14, 2014 |
| Received | Sep 4, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132765
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.