www.fdanews.com/articles/187034-k2m-receives-fda-clearance-for-surgical-planner
K2M Receives FDA Clearance for Surgical Planner
May 31, 2018
K2M announced that its Balance ACS surgical planner device received clearance from the FDA for preoperatively measuring and recording a patient’s skeletal parameters.
The system is used to balance the spine using a 360-degree approach in the axial, coronal and sagittal planes for addressing each anatomical vertebral segment.
The surgical planner allows surgeons to collect baseline measurements used in the creation of patient-specific rods, which can be used with Mesa, Everest and Denali spinal systems.