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K2M's device for spinal balance secures US FDA clearance

K2M Group Holdings, Inc. said the U.S. Food and Drug Administration granted 510(k) clearance to its Ozark cervical plate systems, designed to facilitate spinal balance in certain patients.

The Leesburg, Va.-based medical device maker said the Ozark cervical plate systems are designed for screw fixation to the cervical spine in patients with degenerative disease, deformity, tumor or trauma.