510(k) K122123

6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED by Depuy Mitek, Inc., A Johnson and Johnson Company — Product Code MBI

K122123 is an FDA 510(k) premarket notification submitted by Depuy Mitek, Inc., A Johnson and Johnson Company for the device "6-8MM X 30 MM INTRAFIX PEEK TAPERED SCREW 7-9MM X 30MM INTRAFIX PEEK TAPERED SCREW 8-10MM X 30 MM INTRAFIX PEEK TAPERED". The FDA issued a decision of Substantially Equivalent on October 2, 2012. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Depuy Mitek, Inc., A Johnson and Johnson Company has at least 2 other 510(k) clearances on record.