510(k) K163457

NeuraGen 3D Nerve Guide Matrix by Integra LifeSciences Corporation — Product Code JXI

K163457 is an FDA 510(k) premarket notification submitted by Integra LifeSciences Corporation for the device "NeuraGen 3D Nerve Guide Matrix". The FDA issued a decision of Substantially Equivalent on January 6, 2017. The device falls under product code JXI (Cuff, Nerve), a Class II device regulated under 21 CFR 882.5275. Integra LifeSciences Corporation has at least 10 other 510(k) clearances on record.