K2M, INC.

K2M, Inc. specializes in spinal fixation and orthopaedic hardware. Their devices include non-bioabsorbable spinal bone screws, vertebral body prostheses (like cages for spinal fusion), spinal plates for internal stabilization, and reusable surgical instruments such as retractors and positioning tools for orthopaedic procedures. They also produce interbody systems for spinal fusion, trial implants for procedure planning, and fixation rods for spinal stabilization systems.

K2M, Inc. is headquartered in the United States. Since it operates within the US market, its devices are subject to FDA regulations, including the Unique Device Identifier (UDI) system. The company’s products are listed in the FDA’s UDI database, which helps track authorised devices under US medical device laws. This listing reflects compliance with FDA requirements for device identification and traceability.

K2M, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a regulatory requirement in the US to improve device tracking, transparency, and post-market surveillance. Listing in this database confirms the devices meet FDA standards for identification and classification, though it does not imply individual device approval.

K2M, Inc.’s devices fall under FDA Class I and Class II classifications. Class I devices generally pose minimal risk and may have fewer regulatory controls, while Class II devices 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 hardware for stabilization or fusion.