Device Class Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)
Product Code Orthosis, Spinal Pedicle Fixation (MNI) (1) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (1)