510(k) K061783

KNEE FUSION NAIL by Smith & Nephew, Inc. — Product Code JDS

K061783 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "KNEE FUSION NAIL". The FDA issued a decision of Substantially Equivalent on August 10, 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.