510(k) K243715

Synthes Patient Specific Implants by Synthes GmbH — Product Code GXN

K243715 is an FDA 510(k) premarket notification submitted by Synthes GmbH for the device "Synthes Patient Specific Implants". The FDA issued a decision of Substantially Equivalent on November 12, 2025. The device falls under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable), a Class II device regulated under 21 CFR 882.5330. Synthes GmbH has at least 10 other 510(k) clearances on record.