510(k) K071704

SLEEVE AND BUTTON SOFT TISSUE DEVICES by Biomet Sports Medicine, Inc. — Product Code MBI

K071704 is an FDA 510(k) premarket notification submitted by Biomet Sports Medicine, Inc. for the device "SLEEVE AND BUTTON SOFT TISSUE DEVICES". The FDA issued a decision of Substantially Equivalent on September 17, 2007. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Biomet Sports Medicine, Inc. has at least 10 other 510(k) clearances on record.