FDA Product Code GXN: Plate, Cranioplasty, Preformed, Non-alterable
Leading manufacturers include Fin-Ceramica Faenza S.P.A., Synthes GmbH and CG Bio Co., Ltd..
FDA 510(k) Cleared Plate, Cranioplasty, Preformed, Non-alterable Devices (Product Code GXN)
About Product Code GXN - Regulatory Context
510(k) Submission Activity
55 total 510(k) submissions under product code GXN since 1998, with 55 receiving FDA clearance (average review time: 153 days).
Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.
FDA Review Time
Recent submissions under GXN have taken an average of 205 days to reach a decision - up from 149 days historically. Manufacturers should account for longer review timelines in current project planning.
GXN devices are reviewed by the Neurology panel. Browse all Neurology devices →