Manufacturer
Fusion Robotics, LLCRemi Robotic Navigation System
Country / Region:United States (US)Submission type:Special
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Device details
FDA 510(k) registration fields
- K number
- K223070
- Device name
- Remi Robotic Navigation System
- Company
- Fusion Robotics, LLC
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2022-09-30
- Decision date
- 2022-10-28
- Submission type
- Special
- Technology type
- Robotic Navigation(AI inferred)
- Clinical applications
- Spine SurgeryNavigation SystemRobotic Assistance
- Primary application
- Spine Surgery
- Classification source
- AI classified
Indications for Use
The Remi Robotic Navigation System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or Guide Tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D Imaging scan. The REMI Robotic Navigation System is indicated for assisting the surgeon in placing pedicle screws in vertebrae in the posterior lumbar region (L1-S1). The system is designed for lumbar pedicle screw placement with the patient in the prone position and is compatible with the Accelus LineSider Spinal System.
Intended Use
The Remi Robotic Navigation System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or Guide Tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D Imaging scan. The REMI Robotic Navigation System is indicated for assisting the surgeon in placing pedicle screws in vertebrae in the posterior lumbar region (L1-S1). The system is designed for lumbar pedicle screw placement with the patient in the prone position and is compatible with the Accelus LineSider Spinal System.
Summary parsed at:2026-06-24 04:37:57 UTC
Predicate devices
5Cited as predicate
2Remi Robotic Navigation System
Fusion Robotic Navigation System
2 submissions cite K223070 as a predicate