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The maxMorespine System is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures such as: arthroplasty, nucleotomy, discectomy and foraminotomy.

The maxMorespine System consists of basic cannulas, sheaths, dilators, drills, trephines, forceps, punches, mallet and quidewires which facilitate or compliment the maxMorespine Endoscope (submitted separately under K083552). The System is designed to provide the access and treatment of spinal anatomy and pathology.

This document is a 510(k) summary for the maxMorespine System, which is a spinal endoscopy system. It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria or a study demonstrating the device meets such criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on demonstrating equivalence to existing devices rather than presenting performance data against specific acceptance criteria.

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