FDAnews
www.fdanews.com/articles/114493-fda-clears-k2m-8217-s-plate-systems

FDA Clears K2M’s Plate Systems

February 10, 2009
K2M has received FDA 510(k) clearance for its Cayman Buttress and Thoracolumbar plate systems to help patients suffering from spinal trauma or tumors. Intended to treat the thoracolumbar, lumbar and sacral areas of the spine, the products consist of multiple implant systems, including a buttress plate to address graft expulsion, a lower lumbar sacral plate and additional plating designs to secure and stabilize the anterior column, the company said.