510(k) K062782

INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001 by Inion OY — Product Code MAI

K062782 is an FDA 510(k) premarket notification submitted by Inion OY for the device "INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001". The FDA issued a decision of Substantially Equivalent on November 9, 2006. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Inion OY has at least 10 other 510(k) clearances on record.