K2M Receives 510(k) FDA Clearance for EVEREST System

K2M, a spinal device company, has received 510(k) clearance from the U.S. Food and Drug Administration to market its EVEREST Degenerative Spinal System, according to a company news release.

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The EVEREST System is a top-loading polyaxial pedicle screw system that is able to accommodate multiple levels of fixation rigidity to help surgeons individualize patient care. The system provides for titanium and cobalt chrome rods of two different diameters — 5.5 and 6.0 mm — limiting inventory and increasing adaptability.

The device is designed to maximize osteoporotic and dense bone fixation, and the modified square thread of the locking set screw may reduce the potential for cross-threading. Additionally, the mixed material screw head minimizes splay, which improves the biomechanical performance of the construct.

Read the company news release about FDA approval of the EVEREST Degenerative Spinal System.

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