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When used as a pedicle screw fixation system in the non-cervical posterior spine (T1-S1) in skeletally mature patients, the Presidio Surgical Viking Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) curvatures (i.e., scoliosis, and/or lordosis), (7) tumor, (8) failed previous fusion (i.e. pseudarthrosis).

The Presidio Surgical Viking Lumbar Polyaxial Screw System is a polyaxial pedicle screw system with straight or precontoured crosslink to provide optimal supporting structure for the spinal bodies. The pedicle screw system is a surgically implantable device which is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine. This premarket notification is to add a new crosslink design to the pedicle screw system that was previously cleared.