510(k) K102443

INTRAFIX TIBIAL SHEATH by Depuy Mitek, A Johnson & Johnson Company — Product Code MBI

K102443 is an FDA 510(k) premarket notification submitted by Depuy Mitek, A Johnson & Johnson Company for the device "INTRAFIX TIBIAL SHEATH". The FDA issued a decision of Substantially Equivalent on Oct 20, 2010. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Depuy Mitek, A Johnson & Johnson Company has 61 other 510(k) clearances on record.