510(k) K223330

Certas Plus Programmable Valves by Integra Lifesciences Production Corporation — Product Code JXG

K223330 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Production Corporation for the device "Certas Plus Programmable Valves". The FDA issued a decision of Substantially Equivalent on February 1, 2023. 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 Production Corporation has at least 8 other 510(k) clearances on record.