ORTHOXEL DESIGNATED ACTIVITY COMPANY

Orthoxel Designated Activity Company specializes in orthopaedic devices, including non-bioabsorbable, sterile bone screws, tibia intramedullary nails, and bone nail end-caps. They also produce reusable orthopaedic implant inserters and extractors, as well as aiming arms designed to enhance surgical precision during orthopaedic procedures. These devices are primarily used in procedures involving bone fixation and stabilization.

Orthoxel Designated Activity Company is based in the United States, where it operates as a designated activity company. This designation means the company focuses on specific regulatory activities related to its devices, such as manufacturing or labeling, rather than engaging in broader medical device development or distribution activities. Its devices are subject to U.S. regulatory requirements, including classification and listing in the FDA’s Unique Device Identifier (UDI) database.

Orthoxel Designated Activity Company’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system is used to track and identify medical devices throughout their lifecycle, ensuring transparency and traceability in the regulatory process. This listing helps healthcare providers, regulators, and other stakeholders verify the identity of the devices.

All of Orthoxel Designated Activity Company’s listed devices fall under FDA Class II classification. Class II devices are those that pose moderate risk and require special controls to ensure their safety and effectiveness. These controls may include performance standards, post-market surveillance, or labeling requirements, but they do not typically require pre-market approval like Class III devices. The classification ensures that these devices undergo appropriate regulatory scrutiny while balancing innovation and patient access.