FDA Product Code HBW: Fastener, Plate, Cranioplasty
Leading manufacturers include Stryker Leibinger GmbH & Co KG and Inion OY.
FDA 510(k) Cleared Fastener, Plate, Cranioplasty Devices (Product Code HBW)
About Product Code HBW - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code HBW since 2001, with 7 receiving FDA clearance (average review time: 143 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under HBW have taken an average of 59 days to reach a decision - down from 158 days historically, suggesting improved FDA processing for this classification.
HBW devices are reviewed by the Neurology panel. Browse all Neurology devices →