510(k) K112643 ยท NKB Thoracolumbosacral Pedicle Screw System
FOCUS MIS SYSTEM
| Applicant | L&K BIOMED Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Jan 4, 2012 |
| Received | Sep 12, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112643
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.