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The prodisc® L Instruments are intended for the placement, positioning, and removal of the prodisc® L implants.

The prodisc® L Instruments enable the Centinel prodisc® L disc to be implanted into the disc space. The purpose of this Traditional 510(k) is to seek marketing clearance for four additional prodisc® L Instruments: - IN1575, Hemi Chisel +3mm, 10mm - IN1576, Hemi Chisel +3mm, 12mm - IN1570, Superior Impactor, Medium - IN1571, Superior Impactor, Large These are new instruments, based on similar devices within the existing instrument set.

The prodisc® L Instruments are intended for the placement, positioning, and removal of the prodisc® L implants.

The prodisc® L Instruments enable the Centinel prodisc® L disc to be implanted into the disc space. The purpose of this Traditional 510(k) is to seek marketing clearance for the prodisc® L Instruments.

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.

The Aesculap Implant Systems® activL® Next Generation Instrumentation are indicated for the successful implantation of the Aesculap activL® device. These instruments are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of the activL® device.

The activl ® Next Generation Instrumentation would allow successful implantation of the Aesculap activL® device. These are manual surgical instruments which aid in selecting, placing, and revising the activL® device. These activL® instruments device comprises of trial, trial holders, single and double chisels, implant inserter, depth stop, depth stop driver, and impaction caps.

The prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo instruments are intended for the placement, positioning, and removal of the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo devices.

The prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo Instruments enable the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo devices to be implanted as a single unit into the disc space. Additional instruments are included to allow for the removal of the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo. The purpose of this Traditional 510(k) is to seek marketing clearance for the prodisc® C SK, prodisc® C Nova, and prodisc® C Vivo Instruments.

The M6-C Artificial Cervical Disc Surgical Instruments are intended for the placement and positioning of the M6-C Artificial Cervical Disc.

The surgical implantation of the M6-C Artificial Cervical 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 disc into the desired position to aid in and ensure correct placement within the intervertebral space. Additionally, there is a tamp to independently adjust the posterior position of the M6-C endplates, a removal tool to remove the disc from the disc space, and general surgical instruments to assist in the distraction and mobilization of the disc space. The instruments are composed primarily of surgical stainless steel coated with ME-92 coating to increase corrosion resistance, with some instrument handles also featuring aluminum and Radel materials. Surgical instruments are provided nonsterile and are intended to be reusable. The instruments provided in the kit include Footprint Templates. Trials, Inserters, Fin Cutters, a Tamp, Removal Tools, an Intervertebral Distractor, a Paddle Distractor, a Distractor Spacer, a Slide Hammer, a Retainer, Retainer Pins and Locking Nuts. The M6-C Instrument Tray is multi-layered with various inserts to hold surgical instrumentation in place during handling and storage. The instrument tray is perforated to allow steam to penetrate which will allow sterilization of the contents to occur in a steam autoclave.

The Simplify Disc Inserter FP is intended for the placement and positioning of the Simplify Cervical Artificial Disc.

The instrument set includes a number of surgical instruments designed to facilitate Simplify Cervical Artificial Disc implantation. The Simplify Disc Inserter FP enables the Simplify Disc to be held as a rigid construct in extension and to be inserted as a single unit into the disc space. The instrument set is intended to be used only with the Simplify Cervical Artificial Disc. The purpose of the 510(k) submission is to improve usability of the Simplify Disc Inserter with an updated version referred to as Simplify Disc Inserter FP.