510(k) K162189 · MNH Orthosis, Spondylolisthesis Spinal Fixation
ANAX 5.5 Spinal System
| Applicant | U&I Corporation, Uijeongbu-Si, KR |
| Decision | Substantially Equivalent, Aug 30, 2016 |
| Received | Aug 4, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162189
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.