510(k) K190811 ยท GWO Plate, Cranioplasty, Preformed, Alterable
Optimus NEURO System - Sterile Kit
| Applicant | Osteonic Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Nov 27, 2019 |
| Received | Mar 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190811
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.