510(k) K200794 ยท NKB Thoracolumbosacral Pedicle Screw System
AccelFix Spinal Fixation System
| Applicant | L&K BIOMED Co., Ltd., Yongin-Si, KR |
| Decision | Substantially Equivalent, Oct 20, 2020 |
| Received | Mar 26, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200794
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.