MEDTRONIC, INC. - COLORADO 2™ FX Spinal System

MRI Safety information for:

COLORADO 2™ FX Spinal System

Conditional

MEDTRONIC, INC.

Bone-screw internal spinal fixation system, non-sterile

The COLORADO 2™ FX Spinal System was not directly tested; the CD HORIZON™ Spinal System was selected to represent that system due to similarity of materials and a configuration at least as challenging to MRI imaging as the COLORADO 2™ FX Spinal System. Bench top testing of the worst case system, the CD HORIZON™ Spinal System resulted in classifying the system MR-Conditional in a 1.5 Tesla and 3.0 Tesla MRI system.