510(k) K063117

MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX by Medtronic Neurosurgery — Product Code GXQ

K063117 is an FDA 510(k) premarket notification submitted by Medtronic Neurosurgery for the device "MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX". The FDA issued a decision of Substantially Equivalent on November 3, 2006. The device falls under product code GXQ (Dura Substitute), a Class II device regulated under 21 CFR 882.5910. Medtronic Neurosurgery has at least 10 other 510(k) clearances on record.