510(k) K182473

PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems by K2m, Inc. — Product Code KWQ

K182473 is an FDA 510(k) premarket notification submitted by K2m, Inc. for the device "PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems". The FDA issued a decision of Substantially Equivalent on December 12, 2018. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. K2m, Inc. has at least 10 other 510(k) clearances on record.