510(k) K130302

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

K130302 is an FDA 510(k) premarket notification submitted by Spinevision S.A. for the device "SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT". The FDA issued a decision of Substantially Equivalent on July 30, 2013. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Spinevision S.A. has at least 9 other 510(k) clearances on record.