510(k) K133575

SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM by Spinevision S.A. — Product Code MNH

K133575 is an FDA 510(k) premarket notification submitted by Spinevision S.A. for the device "SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on June 30, 2014. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Spinevision S.A. has at least 9 other 510(k) clearances on record.