Woven Orthopedic Technologies, LLC

Woven Orthopedic Technologies, LLC specializes in bone screw fixation sleeves, which are used to improve stability during orthopedic surgeries. Their primary product line, the Ogmend® system, includes various versions and an implant system specifically designed for spinal and orthopedic fixation. These devices are engineered to support bone healing and structural integrity in surgical applications.

The company is headquartered in the United States. This location allows it to operate within the regulatory framework of the FDA, which governs the classification and authorization of its medical devices.

The devices produced by Woven Orthopedic Technologies, LLC are classified as Class II medical devices by the FDA. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as bone fixation devices. The classification influences the regulatory pathway, including pre-market submissions like 510(k) clearances.

The devices manufactured by Woven Orthopedic Technologies, LLC are listed in the FDA’s 510(k) clearance database, which documents pre-market submissions for Class II devices. Additionally, they are included in the FDA’s Unique Device Identifier (UDI) system, which standardizes device labeling to improve tracking and traceability in healthcare settings.