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The M6-C™ Single Use, Disposable Instrumentation are intended for the placement and positioning of the M6-C Artificial Cervical Disc.

The M6-C™ Artificial Cervical Disc is an intervertebral disc prosthesis designed to permit motion of a functional spinal unit in the cervical spine when replacing a degenerated native disc (PMA P170036). The surgical implantation of the M6-C Cervical Artificial Disc requires specific surgical instruments including: a footprint template and a trial to determine the appropriate size and position of the implant; a fin cutter to create tracks in the superior and inferior vertebral endplates; and an implant inserter to place the artificial disc into the desired position to aid in and ensure correct placement within the intervertebral space. Additionally, these are general surgical instruments to assist in the distraction and mobilization of the disc space. The single use instruments are composed primarily of reinforced polyacrylamide (PAA+50%GF) with some structural components made from surgical stainless steel and are intended to be reusable.