510(k) K162849 ยท PEK Spinous Process Plate
Huvex Interspinous Fixation System
| Applicant | Dio Medical Co., Ltd., Jungwon-Gu Sungnam-Si, KR |
| Decision | Substantially Equivalent, Feb 16, 2017 |
| Received | Oct 11, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162849
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.