K243715 is an FDA 510(k) clearance for the Synthes Patient Specific Implants. This device is classified as a Plate, Cranioplasty, Preformed, Non-alterable (Class II - Special Controls, product code GXN).
Submitted by Synthes GmbH (Zuchwil, CH). The FDA issued a Cleared decision on November 12, 2025, 345 days after receiving the submission on December 2, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5330.
| 510(k) Number | K243715 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2024 |
| Decision Date | November 12, 2025 |
| Days to Decision | 345 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 |