510(k) K160363 ยท JEY Plate, Bone
OPTIMUS CMF SYSTEM
| Applicant | Osteonic Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Oct 20, 2016 |
| Received | Feb 9, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160363
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.