510(k) K140324

RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL by Depuy Mitek, A Johnson And Johnson Company — Product Code MBI

K140324 is an FDA 510(k) premarket notification submitted by Depuy Mitek, A Johnson And Johnson Company for the device "RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL". The FDA issued a decision of Substantially Equivalent on Jul 7, 2014. 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 And Johnson Company has 61 other 510(k) clearances on record.