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K2M Receives FDA Clearance for BACS Patient-Specific Module -

K2M received FDA 510(k) clearance to market BACS® Patient-Specific devices. This fifth module in the BACS platform allows for the creation of pre-contoured rods, rails and templates, and is the company's first patient-specific indication. A machine rolling manufacturing method avoids rod fatigue that may be incurred from the manual, 3-point bending method. When used with data from the BACS Surgical Planner, rods and rails can be shaped into complex multi-contoured designs. BACS Patient-Specific Rods and Rails can be used with the MESA®, EVEREST® and DENALI® systems. (K2M, Inc., 5/30/18)