510(k) K080918

DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0 by Depuy Mitek — Product Code NEW

K080918 is an FDA 510(k) premarket notification submitted by Depuy Mitek for the device "DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0". The FDA issued a decision of Substantially Equivalent on April 23, 2008. The device falls under product code NEW (Suture, Surgical, Absorbable, Polydioxanone), a Class II device regulated under 21 CFR 878.4840. Depuy Mitek has at least 10 other 510(k) clearances on record.