510(k) K160020

Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System by Captiva Spine — Product Code MNH

K160020 is an FDA 510(k) premarket notification submitted by Captiva Spine for the device "Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System". The FDA issued a decision of Substantially Equivalent on March 2, 2016. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Captiva Spine has at least 10 other 510(k) clearances on record.