COLORADO 2 Spinal System

Conditional

MEDTRONIC, INC.

Bone-screw internal spinal fixation system, non-sterile

The COLORADO 2™ 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™ Spinal System. Non-clinical testing demonstrated the CD HORIZON™ Spinal System is MR-Conditional. A patient with this device can be safely scanned immediately after device placement under the following conditions:

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