TDM Co., Ltd.

TDM Co., Ltd. specializes in orthopaedic fixation devices, primarily non-bioabsorbable, non-sterile plates and screws. Their products include systems for stabilizing long bones, such as interlocking nails for the femur, humerus, tibia, and hip, as well as pedicle screws, cervical and lumbar spinal fixation plates, interbody fusion cages, and systems for pectus correction. These devices are designed to aid in bone reconstruction and surgical stabilization.

TDM Co., Ltd. is based in the United States. Since their devices fall under FDA jurisdiction, they must comply with U.S. regulatory requirements, including classification, premarket submissions (like 510(k)s), and Unique Device Identification (UDI) registration. The U.S. location also influences how their devices are listed in global registries, particularly those aligned with FDA pathways.

TDM Co., Ltd.’s devices are classified as Class II under FDA regulations. This classification indicates they pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. Class II devices typically require premarket notifications (510(k)s) to demonstrate substantial equivalence to a predicate device, ensuring compliance with performance standards and labeling requirements before commercialization.

TDM Co., Ltd.’s devices are listed in the FDA’s 510(k) and UDI registries. Listing in these databases means their products have undergone FDA review (via 510(k) submissions or UDI compliance) and are authorized for sale in the U.S. under the respective regulatory pathways. These registries also serve as official sources for tracking device performance, compliance, and post-market surveillance data.

TDM Co., Ltd.’s devices appear under both 510(k) and UDI listings because these are distinct but complementary FDA requirements. The 510(k) pathway is used for premarket submissions to demonstrate that a new device is substantially equivalent to an existing predicate device. Meanwhile, UDI (Unique Device Identification) is a mandatory labeling system that assigns a unique product code to each device variant, enabling better tracking, traceability, and post-market monitoring. Together, they ensure regulatory compliance and transparency throughout the device’s lifecycle.