Op.n(TM) Navigation
Ecential RoboticsOp.n Navigation by Ecential Robotics is a surgical navigation system designed to assist surgeons during spinal surgery. It uses intra-operative 3D imaging to help accurately position surgical instruments and implants like pedicle screws in the thoracolumbar spine. This technology improves surgical precision and patient outcomes by providing real-time navigation based on detailed imaging.
Intended Use
Op.n Navigation is indicated for the positioning of compatible surgical instruments to be used by surgeons during general spinal surgery, specifically for pedicle screw placement in the thoracolumbar spine using intra-operative 3D images.
Technology
The device operates with intra-operative 3D imaging combined with Op.n Navigation software to provide real-time guidance for instrument placement during spinal surgery, employing stereotaxic instrument technology for accurate navigation.
Performance
The device was determined substantially equivalent to predicate devices under 21 CFR 882.4560 and no mention of novel performance testing was described, indicating standard validation to ensure safety and effectiveness per FDA requirements.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/24/2024
5 months - 2
FDA Approval
3/7/2025
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