510(k) K974749

SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS by Cross Medical Products, Inc. — Product Code MNH

K974749 is an FDA 510(k) premarket notification submitted by Cross Medical Products, Inc. for the device "SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS". The FDA issued a decision of SN on March 13, 1998. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Cross Medical Products, Inc. has at least 6 other 510(k) clearances on record.