Simplify Disc Accessory Kit Instructions for Use

8 Pages

Simplify Disc Accessory Kit Instructions for Use IMPORTANT INFORMATION FOR SIMPLIFY DISC ACCESSORY KIT This instruction describes methods of care, cleaning, sterilization and storage of the Simplify Disc Accessory Kit. Recommended surgical procedure, including use of the instrument set, are described in the Simplify Disc Surgical Technique Guide. Intended Use  Device Description  The Simplify Disc Accessory Kit is a collection of supplemental, re-usable instruments for the Simplify Disc. The Core Gauge is used to determine the size of the Simplify Disc core, the Core Removal Tool is intended to facilitate the removal of the core from an implanted Simplify Disc, and the Osteotome is intended to separate the Simplify Disc endplates from the bone interface of an implanted Simplify Disc.  The Accessory Kit Instruments are a collection of supplemental re-usable instruments intended to facilitate removal of a previously implanted Simplify Disc. The Accessory Kit consists of three instruments: a core removal tool (comprised of 4 subcomponents), a core gauge and an osteotome. Use of the Core Removal Tool requires assembly, by the user, of three (3) subcomponents: a housing, a handle core and an internal shaft (small or large size). All of the instruments in the tray are intended for reuse and are pro- vided in a single tray. The instruments are intended to be disassembled and steam sterilized in the tray at the clinical site prior to use.  Simplify Disc Accessory Kit use is determined by the user’s experience and training in surgical procedures. Do not use instruments for any purpose outside the intended use of the instrument, as improper use may seriously affect the safety and function of the product.  1
File Type: PDF
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File Name: NuVasive - 32156-EN - Simplify Disc Accessory Kit Instructions for Use - 2022-06 - Rev K.pdf

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