FEMSELECT LTD

FemSelect Ltd specializes in synthetic polymer ligament grafts, which are used primarily for orthopedic reconstruction. These devices are designed to replace or reinforce ligaments during joint surgeries, such as those involving the knee or other major joints. Their product line includes examples like NeuGuide™ and EnPlace, both of which fall under this category.

FemSelect Ltd is based in the United States. The company focuses on developing synthetic polymer ligament grafts, which are engineered to support orthopedic procedures where natural or biological ligament replacement is required. Their devices are tailored for surgical applications in joint stabilization.

FemSelect Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices, allowing healthcare providers and regulators to access critical information about the devices, such as their classification and intended use.

FemSelect Ltd’s devices are classified as Class II under regulatory frameworks. This classification typically applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as ligament grafts used in orthopedic surgeries. The classification helps determine the regulatory pathway and oversight required for these products.