Biomecânica Indústria e Comércio de Produtos Ortopédicos Ltda.

Biomecânica specializes in orthopaedic cement, specifically non-antimicrobial formulations. Their most common product is bone cement with normal viscosity, designed for surgical applications where bone fixation is required, such as orthopaedic procedures.

The company is based in the United States. This location is relevant for regulatory compliance and distribution, as it aligns with the FDA’s jurisdiction over medical devices marketed in the U.S.

Biomecânica’s devices fall under Class II classification, which typically means they pose moderate risk and require special controls to ensure safety and effectiveness. This classification is determined by regulatory authorities based on factors like the device’s intended use and potential health impact.

Biomecânica’s devices are included in the FDA’s Unique Device Identification (UDI) system. The UDI system helps track and trace medical devices throughout their lifecycle, ensuring transparency and accountability in the supply chain.