510(k) K182711 ยท GWO Plate, Cranioplasty, Preformed, Alterable
Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
| Applicant | Kelyniam Global, Inc., Canton CT, US |
| Decision | Substantially Equivalent, May 21, 2019 |
| Received | Sep 27, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182711
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.