510(k) K160731 ยท MNI Orthosis, Spinal Pedicle Fixation
LumFix Spinal Fixation Sytem
| Applicant | CG Bio Co., Ltd., Seongnam-Si, KR |
| Decision | Substantially Equivalent, Oct 4, 2016 |
| Received | Mar 17, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160731
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.