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 APPLIANCE, FIXATION, SPINAL INTERLAMINAL (KWP) (1) APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY (KWQ) (1) ORTHOSIS, SPINAL PEDICLE FIXATION (MNI) (1) Orthosis, spinal pedicle fixation, for degenerative disc disease (NKB) (1) Orthosis, spondylolisthesis spinal fixation (MNH) (1)