K250334 is an FDA 510(k) clearance for the Fusion Craniofacial Implant. This device is classified as a Plate, Cranioplasty, Preformed, Alterable (Class II - Special Controls, product code GWO).
Submitted by Kelyniam Global, Inc. (Canton, US). The FDA issued a Cleared decision on July 25, 2025, 170 days after receiving the submission on February 5, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5320.
| 510(k) Number | K250334 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2025 |
| Decision Date | July 25, 2025 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWO - Plate, Cranioplasty, Preformed, Alterable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5320 |