Spineart and eCential Robotics received FDA 510(k) Clearance for the PERLA® TL Application for Use with the eCential® Op.n® Navigation System for Robotic Procedures
On 26 August 2026, Spineart and eCential Robotics received FDA 510(k) clearance for the PERLA TL application for use with eCential Robotics’ Op.n Navigation and Robotic-Assisted Platform. The clearance extended the previously established compatibility between the PERLA platform and the Op.n navigation system to robotic-assisted workflows.
The clearance enabled surgeons to integrate Spineart’s PERLA TL Open and MIS pedicle screw systems with real-time navigation and robotic assistance for both open an...