A-SPINE Asia Co., Ltd.

A-Spine Asia Co., Ltd. specializes in spinal orthopedic devices. Their product line includes cervical and lumbar spinal implants like cages and fixation screws, as well as non-sterile orthopedic manual surgical instruments. These devices are designed for spinal stabilization or replacement during surgical procedures.

A-Spine Asia Co., Ltd. is headquartered in Beijing, China. The company’s devices are classified under both EU and FDA frameworks, including Class I, Class II, Class IIb, and Class III categories, reflecting their intended use and risk levels. Their products are listed in the EU’s eudamed registry and have undergone FDA 510(k) clearance, demonstrating compliance with international regulatory standards.

A-Spine Asia Co., Ltd.’s devices are recorded in the EU’s eudamed registry, which tracks medical devices authorized under EU regulations. Additionally, their products have completed the FDA’s 510(k) clearance process, meaning they are listed in the FDA’s database of cleared devices in the United States.

A-Spine Asia Co., Ltd.’s devices fall into multiple regulatory classes depending on their risk level and intended use. In the EU and FDA systems, their products are classified as Class I (low-risk), Class II (moderate-risk), Class IIb (higher-risk), and Class III (high-risk), such as certain spinal implants. Classification determines the regulatory scrutiny and authorization requirements they must meet.