510(k) K141911 ยท GWO Plate, Cranioplasty, Preformed, Alterable
OPTIMUS NEURO SYSTEM
| Applicant | Osteonic Co., Ltd., Fullerton CA, US |
| Decision | Substantially Equivalent, Feb 10, 2015 |
| Received | Jul 15, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141911
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.