510(k) K141332

Captiva Spine SmartLOX Cervical Plate System by Captiva Spine — Product Code KWQ

K141332 is an FDA 510(k) premarket notification submitted by Captiva Spine for the device "Captiva Spine SmartLOX Cervical Plate System". The FDA issued a decision of Substantially Equivalent on June 11, 2015. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Captiva Spine has at least 10 other 510(k) clearances on record.