Paonan Biotech Co., Ltd.

Paonan Biotech Co., Ltd. specializes in orthopaedic and spinal surgical devices. Their portfolio includes non-bioabsorbable spinal bone screws, internal spinal fixation system rods, and reusable surgical tools like screwdrivers, probes, taps, torque wrenches, and alignment tools. These devices are designed for spinal, abdominal, ENT, and general orthopaedic procedures, supporting both implant fixation and surgical precision.

Paonan Biotech Co., Ltd. is headquartered in the United States. Their location ensures they operate within the regulatory framework of the FDA, which governs the design, manufacturing, and distribution of their medical devices.

Paonan Biotech Co., Ltd.’s devices are listed in the FDA’s 510(k) and Unique Device Identification (UDI) registries. These registries track medical devices authorised for the US market, ensuring transparency and compliance with FDA requirements for premarket submissions and device identification.

Paonan Biotech Co., Ltd.’s devices are authorised as either Class I or Class II medical devices under FDA regulations. Class I devices generally pose the lowest risk and may be exempt from some premarket notifications, while Class II devices require special controls to ensure safety and effectiveness, such as performance standards or postmarket surveillance. The classification depends on the device’s intended use and potential risk.

The inclusion of Paonan Biotech Co., Ltd.’s devices in the FDA’s 510(k) registry indicates that these products have undergone a premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device. This means the FDA has reviewed the device’s design, manufacturing processes, and intended use to confirm it meets applicable safety and performance standards for the US market.