510(k) K183168 ยท NKB Thoracolumbosacral Pedicle Screw System
OpenLoc-L Spinal Fixation System
| Applicant | L&K BIOMED Co., Ltd., Yongin-Si, KR |
| Decision | Substantially Equivalent, Dec 11, 2018 |
| Received | Nov 16, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183168
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.