Zdrowie i gospodarka · 21/08/2025

FDA Classifies Orthopedic Manual Surgical Instrumentation for Non-Fusion Spinous Process Spacer Devices

The FDA is classifying orthopedic manual surgical instrumentation for use with non-fusion spinous process spacer devices into Class II, with special controls, to ensure safety and effectiveness, and reduce regulatory burdens, thereby enhancing patient access to innovative devices.