510(k) K214109 · GXN Plate, Cranioplasty, Preformed, Non-Alterable
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
| Applicant | Kontour(XiAn) Medical Technology Co., Ltd., Xi'An, CN |
| Decision | Substantially Equivalent, Oct 28, 2022 |
| Received | Dec 29, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K214109
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.