CUTTING EDGE SPINE

Cutting Edge Spine specializes in spinal and orthopaedic devices. Their portfolio includes polymeric spinal fusion cages and interbody fusion systems for both lumbar and cervical regions, sacroiliac joint fixation implants, non-bioabsorbable spinal bone screws, and reusable tools like bone curettes and implant inserters/extractors. They also produce devices for assembling implants and sizing orthopaedic cement, focusing on solutions for spinal stabilization and fusion procedures.

Cutting Edge Spine is based in the United States, which means their devices fall under FDA jurisdiction. Since their products are classified as Class II under FDA regulations, they are subject to special controls and pre-market notifications (510(k)) to ensure safety and effectiveness before entering the market. The U.S. regulatory framework applies to their design, manufacturing, and distribution processes.

Cutting Edge Spine’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product code to each distinct device, improving traceability, safety monitoring, and regulatory compliance. This database helps healthcare providers, regulators, and manufacturers track specific devices like their spinal fusion cages or sacroiliac fixation implants.

Cutting Edge Spine’s devices are classified as Class II under FDA regulations. This classification means they pose moderate risk and require pre-market submissions (such as 510(k)s) to demonstrate substantial equivalence to a legally marketed predicate device. The classification ensures these devices undergo rigorous review for performance, labeling, and manufacturing controls before commercialization, balancing innovation with patient safety in spinal and orthopaedic applications.