510(k) K123668

ORTHOCORD by Depuy Mitek, Inc., A Johnson and Johnson Company — Product Code NEW

K123668 is an FDA 510(k) premarket notification submitted by Depuy Mitek, Inc., A Johnson and Johnson Company for the device "ORTHOCORD". The FDA issued a decision of Substantially Equivalent on February 26, 2013. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840. Depuy Mitek, Inc., A Johnson and Johnson Company has at least 2 other 510(k) clearances on record.