K214109 is an FDA 510(k) clearance for the PEEK Patient Specific Cranial/Craniofacial Implant(PSCI). This device is classified as a Plate, Cranioplasty, Preformed, Non-alterable (Class II - Special Controls, product code GXN).
Submitted by Kontour(Xi?An) Medical Technology Co., Ltd. (Xi'An, CN). The FDA issued a Cleared decision on October 28, 2022, 303 days after receiving the submission on December 29, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5330.
| 510(k) Number | K214109 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2021 |
| Decision Date | October 28, 2022 |
| Days to Decision | 303 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXN - Plate, Cranioplasty, Preformed, Non-alterable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5330 |