510(k) K103147

NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM by Medyssey Co, Ltd. — Product Code MNI

K103147 is an FDA 510(k) premarket notification submitted by Medyssey Co, Ltd. for the device "NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM". The FDA issued a decision of Substantially Equivalent on December 16, 2010. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Medyssey Co, Ltd. has at least 10 other 510(k) clearances on record.