510(k) K103831

DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809 by Depuy Mitek, A Johnson & Johnson Company — Product Code MAI

K103831 is an FDA 510(k) premarket notification submitted by Depuy Mitek, A Johnson & Johnson Company for the device "DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809". The FDA issued a decision of Substantially Equivalent on Jul 21, 2011. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Depuy Mitek, A Johnson & Johnson Company has 61 other 510(k) clearances on record.