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The Ingenix™ Spinal System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of the following acute and chromic instabilities of thoracic, lumbar, and sacral spine; degenerative spondylolisthesis, with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra with autogenous bone graft, and failed previous fusion (pseudarthrosis).

The Ingenix™ Spinal System (originally cleared as "Arisstos Spinal System") is an internal fixation device for spinal surgery consisting of rods, screws, and connectors available in various sizes to accommodate patient anatomy. A series of manual instruments intended to assist in the insertion and placement of the implants, such as taps, drivers, and rod benders, is provided in separate instrument trays.

The subject rods, screws, and connectors are manufactured of Ti-6Al-4V titanium alloy per ASTM F136. Additionally, 5.5mm and 6.0mm cobalt chrome rods are also available, conforming to ASTM F1537. All instruments are manufactured from stainless steel, aluminum, and select polymers.

The subject submission seeks to gain clearance for the following:

• . Minor modifications made to screws
• . Size expansion for the polyaxial deformity screws
• . Sterile packaging of a kit configuration

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