510(k) K182544 ยท NKB Thoracolumbosacral Pedicle Screw System
AccelFix Spinal Fixation System
| Applicant | L&K BIOMED Co., Ltd., Yongin-Si, KR |
| Decision | Substantially Equivalent, May 28, 2019 |
| Received | Sep 17, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182544
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.