ELITE SURGICAL SUPPLIES (PTY) LTD

Elite Surgical Supplies (PTY) LTD specializes in spinal fixation devices. Their portfolio includes non-bioabsorbable spinal bone screws, set screws, and rod adaptors for spinal stabilization. They also produce spinal fixation plates, polymeric interbody fusion cages, and components like rods and hooks for internal spinal fixation systems. Additionally, they manufacture orthopaedic surgical procedure kits designed for single-use, non-medicated applications.

Elite Surgical Supplies (PTY) LTD is based in the United States, which means their devices are designed to comply with FDA regulations. Since they operate domestically, their products are subject to FDA oversight, including classification under Class I or Class II, and must adhere to submission requirements like 510(k) clearances and UDI registration.

Elite Surgical Supplies’ devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) process demonstrates that their devices meet FDA standards for safety and effectiveness by showing substantial equivalence to a predicate device. The UDI system ensures traceability and transparency in the supply chain, helping healthcare providers and regulators track devices throughout their lifecycle.

Elite Surgical Supplies’ devices fall under FDA classifications of Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway, such as 510(k) submissions for Class II, ensuring compliance with applicable FDA requirements.