Incite Innovation, LLC

Incite Innovation, LLC specializes in polymeric spinal fusion cages, specifically designed for spinal interbody fusion. Their most common product category is the polymeric spinal interbody fusion cage, including anchored cervical interbody devices. These devices are intended to provide structural support and facilitate bone growth between vertebrae in the cervical spine, helping stabilize the spine during surgical procedures.

Incite Innovation, LLC is based in the United States. As a US-based manufacturer, its devices are subject to FDA regulations. The company’s products are authorised through the FDA’s 510(k) pathway and are listed under the FDA’s Unique Device Identification (UDI) system, ensuring traceability and compliance with US medical device regulations.

Incite Innovation, LLC’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identification (UDI) system. These registries track authorised medical devices in the US, including their classification, intended use, and compliance status. The inclusion in these databases confirms that the devices meet FDA requirements for market authorisation.

Incite Innovation, LLC’s devices fall under FDA Class II classification. This classification is assigned based on the level of risk associated with the device. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness. The company’s products, such as anchored cervical interbody fusion cages, are authorised through the 510(k) pathway, which demonstrates that they meet FDA requirements for this classification.