510(k) K190567 ยท NKB Thoracolumbosacral Pedicle Screw System
KeYi Spinal Fixation System
| Applicant | Beijing Keyi Medical Device Technology Co., Ltd., Beijing, CN |
| Decision | Substantially Equivalent, May 8, 2019 |
| Received | Mar 6, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190567
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.