510(k) K222229 ยท NKB Thoracolumbosacral Pedicle Screw System
Advanced LumFix Spinal Fixation System
| Applicant | CG Bio Co., Ltd., Hwaseong-Si, KR |
| Decision | Substantially Equivalent, May 25, 2023 |
| Received | Jul 25, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222229
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.