510(k) K150380 ยท NKB Thoracolumbosacral Pedicle Screw System
ProMIS Fixation System
| Applicant | Premia Spine, Ltd., Ramat Poleg, IL |
| Decision | Substantially Equivalent, Jul 17, 2015 |
| Received | Feb 13, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150380
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.