510(k) K113219

ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM by Ellipse Technologies, Inc. — Product Code HSB

K113219 is an FDA 510(k) premarket notification submitted by Ellipse Technologies, Inc. for the device "ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM". The FDA issued a decision of Substantially Equivalent on October 19, 2012. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Ellipse Technologies, Inc. has at least 10 other 510(k) clearances on record.