510(k) K111115

CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM by Captiva Spine, Inc. — Product Code MNI

K111115 is an FDA 510(k) premarket notification submitted by Captiva Spine, Inc. for the device "CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on September 13, 2011. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Captiva Spine, Inc. has at least 10 other 510(k) clearances on record.