IMAGE NAVIGATION LTD

Image Navigation Ltd specializes in spinal fixation systems. Their portfolio includes devices like the IGI Posterior MINILOCK, IGI Anterior MINILOCK, and the IGI system, which are primarily designed for internal spinal stabilization and fixation procedures. These devices are engineered to support surgical interventions aimed at maintaining spinal alignment and structural integrity.

Image Navigation Ltd is based in Israel. The company’s location is relevant for understanding its regulatory framework, manufacturing standards, and compliance with local and international medical device regulations.

Image Navigation Ltd’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry tracks devices that have undergone conformity assessment procedures, such as those classified under EU Class IIa, ensuring transparency and traceability within the EU market.

Image Navigation Ltd’s devices, including the IGI Posterior MINILOCK, IGI Anterior MINILOCK, and IGI system, fall under EU Class IIa classification. This classification is determined based on the risk associated with the device’s intended use and its potential impact on patient safety. Class IIa devices require a higher level of scrutiny than Class I but are considered lower risk than Class IIb or Class III devices, necessitating specific conformity assessment procedures.