510(k) K190471 · NKB Thoracolumbosacral Pedicle Screw System
4CIS® Chiron Spinal Fixation System
| Applicant | Solco Biomedical Co., Ltd., Pyeongtaek, KR |
| Decision | Substantially Equivalent, Jul 24, 2019 |
| Received | Feb 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190471
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.