510(k) K092388

DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO by Integra LifeSciences Corporation — Product Code GXQ

K092388 is an FDA 510(k) premarket notification submitted by Integra LifeSciences Corporation for the device "DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO". The FDA issued a decision of Substantially Equivalent on January 21, 2010. 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.