510(k) K152370

PRECICE Trauma Nail System by Ellipse Technologies, Incorporated — Product Code HSB

K152370 is an FDA 510(k) premarket notification submitted by Ellipse Technologies, Incorporated for the device "PRECICE Trauma Nail System". The FDA issued a decision of Substantially Equivalent on December 22, 2015. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Ellipse Technologies, Incorporated has at least 6 other 510(k) clearances on record.