Remex Spine Surgery Navigation Instrument
Remex Medical Corp.The Remex Spine Surgery Navigation Instrument is designed to assist surgeons in precisely positioning surgical tools and spinal implants during spinal surgeries. It works by integrating fluoroscopic and CT images to guide procedures like pedicle screw placement, enhancing surgical accuracy and patient safety.
Intended Use
Used with Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II for precise positioning of surgical instruments or spinal implants during general spine surgery relative to fluoroscopic or CT imagery.
Technology
The device consists of specialized surgical tools (Nav Awl, Nav Drill Guide, Nav Tap, Nav Screwdriver, Nav Handle) designed for image-guided navigation. It functions by registering intraoperative 2D fluoroscopic images to preoperative 3D CT images, facilitating precise surgical instrument placement during spine surgery. It uses software validated per FDA and IEC 62304 standards with biocompatible materials.
Performance
Verification and validation activities including software testing, risk assessment, design verification, and biocompatibility evaluation were completed, demonstrating that the device performs as safely and effectively as predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/18/2024
25 days - 2
FDA Approval
12/13/2024
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