510(k) K182416 ยท NKB Thoracolumbosacral Pedicle Screw System
NOVA Minimally Invasive System
| Applicant | Baui Biotech Co., Ltd., New Taipei City, TW |
| Decision | Substantially Equivalent, Jun 11, 2019 |
| Received | Sep 4, 2018 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K182416
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.