510(k) K133950

ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.) by Bioretec, Ltd. — Product Code HTY

K133950 is an FDA 510(k) premarket notification submitted by Bioretec, Ltd. for the device "ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)". The FDA issued a decision of Substantially Equivalent on January 22, 2014. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Bioretec, Ltd. has at least 8 other 510(k) clearances on record.