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The Mega Plus MIS Spine 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: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). The Mega Plus MIS Spine System can be used in an open approach and percutaneous approach.

The Mega Plus MIS Spine System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, locking bolts, and a transverse (cross) link. Various sizes of these implants are available. Mega Plus MIS Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Mega Plus MIS Spine System can either be used in an open approach and/or a percutaneous with minimally invasive (MIS) surgical approach. All products are made of titanium alloy (ASTM F136) and CoCrMo alloy (ASTM F1537) approved for medical use. The implants will be provided non-sterile. The locking bolts utilized as part of the proposed system are identical to those of the Mega Plus Spine System (K173180, K183080). The crosslinks and additional universal instrument components that may be utilized as part of the subject system were cleared previously for the Mega Plus Spine System (K173180, K183080).