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www.fdanews.com/articles/176042-k2m-wins-expanded-indications-for-spinal-systems

K2M Wins Expanded Indications for Spinal Systems

April 6, 2016

K2M Group Holdings has won FDA clearance for the expanded indications of its MESA Mini and DENALI Mini spinal systems, the Leesburg, Va.-based devicemaker announced Wednesday.

Both systems stabilize the posterior cervical and thoracic spine. As a result of the FDA’s decision, they now are indicated for use in the posterior cervical spine, from C1 to C7.

The systems previously were cleared for use in the posterior thoracic spine, from T1-T3. — Anisa Jibrell