Ortoma Submits US FDA 510(k) Application for Spine Module
Ortoma has submitted a regulatory application for FDA 510(k) clearance of its spine module to be included in the platform Ortoma Treatment Solution (OTS). The spine module is a pre-operative planning solution for spine surgery. The OTS platform is a surgical system that is assisted by AI (Artificial Intelligence) for improved accuracy, efficiency and surgical outcome.The submission has been accepted for review by the US FDA (US Food & Drug Administration). The result of the review is expected during the 2[nd] half-year 2021. After receiving FDA 510(k) clearance, the product will be