510(k) K092771

DYNA LOCKING IM NAIL by U&I Corp. — Product Code HSB

K092771 is an FDA 510(k) premarket notification submitted by U&I Corp. for the device "DYNA LOCKING IM NAIL". The FDA issued a decision of Substantially Equivalent on December 2, 2009. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. U&I Corp. has at least 10 other 510(k) clearances on record.