510(k) K163456

DuraGen Secure Dural Regeneration Matrix by Integra LifeSciences Corporation — Product Code GXQ

K163456 is an FDA 510(k) premarket notification submitted by Integra LifeSciences Corporation for the device "DuraGen Secure Dural Regeneration Matrix". The FDA issued a decision of Substantially Equivalent on January 6, 2017. The device falls under product code GXQ (Dura Substitute), a Class II device regulated under 21 CFR 882.5910. Integra LifeSciences Corporation has at least 10 other 510(k) clearances on record.