510(k) K073643

TRANS1 AXIALIF 2-LEVEL OR II SYSTEM by Trans1 Incorporated — Product Code KWQ

K073643 is an FDA 510(k) premarket notification submitted by Trans1 Incorporated for the device "TRANS1 AXIALIF 2-LEVEL OR II SYSTEM". The FDA issued a decision of Substantially Equivalent on Apr 28, 2008. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Trans1 Incorporated has 8 other 510(k) clearances on record.