510(k) K083076

STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 by Medtronic Neurosurgery — Product Code JXG

K083076 is an FDA 510(k) premarket notification submitted by Medtronic Neurosurgery for the device "STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836". The FDA issued a decision of Substantially Equivalent on November 20, 2008. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Medtronic Neurosurgery has at least 10 other 510(k) clearances on record.