510(k) K100888

MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM by Lanx, Inc. — Product Code KWP

K100888 is an FDA 510(k) premarket notification submitted by Lanx, Inc. for the device "MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on November 15, 2010. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Lanx, Inc. has at least 10 other 510(k) clearances on record.