510(k) K052630

ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) by Depuy Mitek, A Johnson & Johnson Company — Product Code HWC

K052630 is an FDA 510(k) premarket notification submitted by Depuy Mitek, A Johnson & Johnson Company for the device "ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)". The FDA issued a decision of Substantially Equivalent on Oct 17, 2005. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Depuy Mitek, A Johnson & Johnson Company has 61 other 510(k) clearances on record.