510(k) K181902

Codman Certas Plus Electronic Tool Kit by Integra Lifesciences Corp. — Product Code JXG

K181902 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Corp. for the device "Codman Certas Plus Electronic Tool Kit". The FDA issued a decision of Substantially Equivalent on October 25, 2018. 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.