510(k) K092124

AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II by Trans1 Incorporated — Product Code KWQ

K092124 is an FDA 510(k) premarket notification submitted by Trans1 Incorporated for the device "AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II". The FDA issued a decision of Substantially Equivalent on Jan 21, 2010. 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.