ADRIA SRL

Adria Srl specializes in orthopaedic and spinal surgical instruments. Their product line includes single-use devices like vertebral bone biopsy procedure kits and percutaneous diskectomy systems, as well as reusable tools such as cannulated surgical drill bits and bone access cannulas. They also produce devices for dispensing orthopaedic cement or bone fillers, including cement injection cannulas and vertebroplasty injector kits. These instruments are designed for procedures involving spinal and bone interventions.

Adria Srl is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies their products under Class I and Class II categories, which determines the level of scrutiny and reporting requirements for each device type. The U.S. location also means their devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance tracking.

Adria Srl’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized approach to identify medical devices throughout their distribution and helps ensure transparency, traceability, and compliance with regulatory requirements. This listing is relevant for tracking devices like their vertebral biopsy kits, diskectomy systems, and orthopaedic cement dispensers.

Adria Srl’s devices are classified under the FDA’s Class I and Class II categories. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with, such as spinal or bone interventions. This classification influences regulatory oversight and reporting obligations.