Search Results

The CrossRoads Screw System is indicated for fracture repair and fixation, reconstruction and arthrodesis of bones appropriate for the size of the device.

The CrossRoads Screw System is comprised of bone screws having various features in a variety of diameters and lengths to accommodate differing patient anatomy.

This document is a 510(k) premarket notification for the "CrossRoads Screw System." It does not contain information about acceptance criteria or a study proving that a device meets such criteria, as it pertains to a medical device (screw system) rather than a diagnostic or AI-based device that would typically have performance metrics like sensitivity, specificity, or accuracy.

The document is a submission to the FDA seeking clearance for a bone fixation device, asserting its substantial equivalence to previously cleared predicate devices. The information provided is primarily regulatory and descriptive.

Therefore, I cannot extract the requested information regarding acceptance criteria and device performance studies from this document.

Ask a specific question about this device