510(k) K083077 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
ULC SPINAL PEDICLE SCREW SYSTEM
| Applicant | Otis Biotech Co., Ltd., Siheung-Si, Gyounggi-Do, KR |
| Decision | Substantially Equivalent, Oct 26, 2009 |
| Received | Oct 16, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083077
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.