510(k) K182598 · NKB Thoracolumbosacral Pedicle Screw System
VersaLink Fixation System
| Applicant | Premia Spine, Ltd., Westfield NJ, US |
| Decision | Substantially Equivalent, Nov 13, 2018 |
| Received | Sep 20, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182598
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.