510(k) K250334

Fusion Craniofacial Implant; Fusion Skull Implant by Kelyniam Global, Inc. — Product Code GWO

K250334 is an FDA 510(k) premarket notification submitted by Kelyniam Global, Inc. for the device "Fusion Craniofacial Implant; Fusion Skull Implant". The FDA issued a decision of Substantially Equivalent on July 25, 2025. The device falls under product code GWO (Plate, Cranioplasty, Preformed, Alterable), a Class II device regulated under 21 CFR 882.5320. Kelyniam Global, Inc. has at least 3 other 510(k) clearances on record.