510(k) K092395

OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM by Integra Lifesciences Corp. — Product Code JXG

K092395 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Corp. for the device "OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM". The FDA issued a decision of Substantially Equivalent on November 19, 2009. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Integra Lifesciences Corp. has at least 10 other 510(k) clearances on record.