510(k) K183352 ยท GWO Plate, Cranioplasty, Preformed, Alterable
Optimus Neuro System
| Applicant | Osteonic Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Jan 2, 2019 |
| Received | Dec 3, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183352
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.