510(k) Orthopedic Devices

FDA 510(k) Cleared Orthopedic Devices

This page lists all 17685 medical devices in the Orthopedic specialty that have been submitted to the FDA through the 510(k) premarket notification process. Joint implants, surgical navigation, bone fixation and robotic surgery systems.

• 17668 devices cleared as substantially equivalent to a predicate device.
• Average time to FDA decision: 122 days.
• Records available from 1976 to the present.
• Filter by product code using the sidebar to narrow results by device type.