NovaSpine

NovaSpine specializes in spinal implants, specifically the SOCORE Spinal Stabilization System. This system includes various configurations of spinal stabilization devices, some of which are designed for sterile use and others for non-sterile applications. These implants are intended for surgical procedures requiring internal fixation of the spine.

NovaSpine is based in France and focuses on the design and production of advanced implants and instruments tailored for spinal surgery. The company’s primary product line, the SOCORE Spinal Stabilization System, is engineered to provide surgical stabilization for spinal procedures.

NovaSpine’s SOCORE Spinal Stabilization System is registered in the EU through the eudamed database, which is the official EU registry for medical devices. This registration reflects the device’s compliance with EU requirements for classification and market surveillance.

The SOCORE Spinal Stabilization System falls under Class IIb classification in the EU. This classification is determined by factors such as the device’s intended use, potential risks, and the degree of intervention in the body. Class IIb devices require additional scrutiny to ensure safety and performance, including conformity assessment procedures like a Notified Body review.