Medical Device Manufacturer · FR , Gieres

Ecential Robotics - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2022

Recent clearances: Op.n(TM) Navigation, Spine Navigation and Robotic-Assistance Device, SURGIVISIO Device

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ecential Robotics Orthopedic ✕

5 devices

1-5 of 5

Cleared Jul 22, 2026

Op.n™ Spine Navigation and Robotic Guidance

Orthopedic · 110d

Cleared Mar 07, 2025

Op.n(TM) Navigation

Orthopedic · 164d

Cleared Jun 14, 2024

Spine Navigation and Robotic-Assistance Device

Orthopedic · 260d

Cleared Jul 27, 2023

SURGIVISIO Device

Orthopedic · 30d

Cleared Jul 06, 2022

SURGIVISIO Device

Orthopedic · 90d