510(k) K181639

Panta 2 Arthrodesis Nail System by Integra LifeSciences Corporation — Product Code HSB

K181639 is an FDA 510(k) premarket notification submitted by Integra LifeSciences Corporation for the device "Panta 2 Arthrodesis Nail System". The FDA issued a decision of Substantially Equivalent on November 2, 2018. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Integra LifeSciences Corporation has at least 10 other 510(k) clearances on record.