510(k) K080879

ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM by Bioretec, Ltd. — Product Code HTY

K080879 is an FDA 510(k) premarket notification submitted by Bioretec, Ltd. for the device "ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM". The FDA issued a decision of Substantially Equivalent on June 24, 2008. 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.