510(k) K231844 · NKB Thoracolumbosacral Pedicle Screw System
ProMIS Fixation System
| Applicant | Premia Spine, Ltd., Ramat Poleg, Netanya, IL |
| Decision | Substantially Equivalent, Jul 7, 2023 |
| Received | Jun 22, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231844
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.