510(k) K062912

SCIENT'X SPINAL SYSTEM by Scient'X — Product Code MNI

K062912 is an FDA 510(k) premarket notification submitted by Scient'X for the device "SCIENT'X SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on February 5, 2007. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Scient'X has at least 10 other 510(k) clearances on record.