510(k) K162801 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
CastleLoc Spinal Fixation System
| Applicant | L&K BIOMED Co., Ltd., Yongin-Si, KR |
| Decision | Substantially Equivalent, Nov 3, 2016 |
| Received | Oct 5, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162801
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.