The Food and Drug Administration (FDA) is classifying the intraoperative surgical angle measurement tool into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the intraoperative surgical angle measurement tool. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
US Federal Register - FDA Rules · July 24, 2026
Medical Devices; Orthopedic Devices; Classification of the Intraoperative Surgical Angle Measurement Tool
FDA classifies intraoperative surgical angle measurement tool as class II device subject to special controls.
Published by US Federal Register - FDA Rules. HealthSignal links to the original document; the summary above is extracted from the source text.