Disior, Ltd.

Disior, Ltd. specializes in computer-aided design and manufacturing (CAD/CAM) software for medical use. Their portfolio includes imaging-integrated systems like the SMART Bun-Yo-Matic™ for CT and X-ray guided procedures, as well as software tools such as the ENOS Software Guided External Fixation System and Bonelogic for orthopedic surgical planning and bone analysis. These solutions are designed to assist clinicians in precision medical interventions.

Disior, Ltd. is based in the United States, which means its devices are subject to FDA regulations. Since the company’s products are classified as Class II devices, they must comply with FDA requirements for performance standards, labeling, and post-market surveillance. The U.S. regulatory environment ensures these devices meet safety and effectiveness criteria before entering the market.

Disior, Ltd.’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The 510(k) process demonstrates that a device is substantially equivalent to a legally marketed predicate device, while UDI registration ensures traceability and transparency in the supply chain. These listings help healthcare providers, regulators, and patients verify device compliance and safety.

Disior, Ltd.’s devices are classified as Class II under FDA regulations, which means they pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. This classification requires manufacturers to follow specific labeling, performance standards, and post-market surveillance requirements, ensuring that devices like their CAD/CAM software and imaging-guided systems meet rigorous regulatory standards.