510(k) K141284

CASPIAN SPINAL SYSTEM by K2m, Inc. — Product Code KWP

K141284 is an FDA 510(k) premarket notification submitted by K2m, Inc. for the device "CASPIAN SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on July 23, 2014. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. K2m, Inc. has at least 10 other 510(k) clearances on record.