Synthes

Synthes specializes in orthopaedic and craniofacial fixation devices. Its portfolio includes non-bioabsorbable orthopaedic fixation plates and screws for bone stabilization, spinal implants like trial devices and interbody fusion cages, spinal screws and plates, and craniofacial fixation plates for non-customized facial reconstruction. The company also produces surgical instrument racks to organize implants and tools.

Synthes is based in the United States, which means its devices must comply with U.S. regulatory requirements, including those set by the FDA. Since the company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, they are subject to U.S. medical device regulations, including classification under FDA’s Class I and Class II categories.

Synthes’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.

Synthes’ devices fall under FDA’s Class I and Class II categories. Class I generally includes low-risk devices requiring general controls, while Class II involves special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, risk level, and potential impact on patient health.

Listing in the FDA’s UDI database means each of Synthes’ devices has a unique identifier assigned to it, improving traceability and reducing medical errors. This system helps healthcare providers quickly verify device details, such as manufacturer, model, and batch information, ensuring proper use and compliance with regulatory standards.