510(k) K061019

TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS by Smith & Nephew, Inc. — Product Code JDS

K061019 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS". The FDA issued a decision of Substantially Equivalent on June 6, 2006. The device falls under product code JDS (Nail, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.