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The Spinal Simplicity Spinous Process Fusion (SPF) Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: - · degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic studies); - · spondylolisthesis; - · trauma (i.e., fracture or dislocation); and/or - tumor. The SPF-Plate is intended for use with bone graft material and is not intended for stand-alone use. The device may be implanted via an open (T1-S1) or percutaneous (L1-S1) approach.

The Spinal Simplicity Spinous Process Fusion (SPF) Plate is a minimally invasive, spinous process fusion plate designed for attachment to the posterior, non-cervical spine at the spinous processes through its bilateral locking Plates, and it is intended for use with bone graft fusion material placed within the device. The Spinal Simplicity Spinous Process Fusion (SPF) Plate consists of a Body/Post. Plates, and Fasteners that together form a construct to provide supplemental fusion and stabilization of spinal segments. The components are available in a range of sizes to accommodate varying patient anatomy. Spinal Simplicity Spinous Process Fusion (SPF) Plates are composed of titanium alloys (per ASTM F136 and ASTM F1472).