KH073

The CARMEN plate and bone screw components are intended for anterior inter-body screw fixation from C2-TI. The plate and bone screw components are indicated for use together with the Carmen Anterior Cage in the temporary stabilization of the anterior spine during the development of spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radio-graphic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudoarthrosis, and/or 6) failed previous fusions.