510(k) K122332

TOWERLOX PEDICLE SCREW SYSTEM by Captiva Spine — Product Code MNI

K122332 is an FDA 510(k) premarket notification submitted by Captiva Spine for the device "TOWERLOX PEDICLE SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on October 16, 2012. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Captiva Spine has at least 10 other 510(k) clearances on record.