510(k) K052799

MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM by Bonutti Research, Inc. — Product Code MAI

K052799 is an FDA 510(k) premarket notification submitted by Bonutti Research, Inc. for the device "MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM". The FDA issued a decision of Substantially Equivalent on December 16, 2005. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Bonutti Research, Inc. has at least 10 other 510(k) clearances on record.