510(k) K052211

DUREPAIR DURA REGENERATION MATRIX by Medtronic Neurosurgery — Product Code GXQ

K052211 is an FDA 510(k) premarket notification submitted by Medtronic Neurosurgery for the device "DUREPAIR DURA REGENERATION MATRIX". The FDA issued a decision of Substantially Equivalent on September 14, 2005. 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.