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Ecential Robotics

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories2
Latest FDA decision2026-07-22
TypeNumberDevice NameCodeDateActions
510(k) K261113 Op.n™ Spine Navigation and Robotic GuidanceOLO2026-07-22 View
510(k) K242914 Op.n(TM) NavigationOLO2025-03-07 View
510(k) K233228 Spine Navigation and Robotic-Assistance DeviceOLO2024-06-14 View
510(k) K231886 SURGIVISIO DeviceOLO2023-07-27 View
510(k) K221028 SURGIVISIO DeviceOLO2022-07-06 View
510(k) K220946 SURGIVISIO DeviceOWB2022-04-15 View
510(k) K220627 SURGIVISIO DeviceOWB2022-03-18 View