510(k) K992611

MITEK ROTATOR CUFF QUICKANCHOR PLUS by Mitek Products — Product Code HWC

K992611 is an FDA 510(k) premarket notification submitted by Mitek Products for the device "MITEK ROTATOR CUFF QUICKANCHOR PLUS". The FDA issued a decision of Substantially Equivalent on September 22, 1999. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Mitek Products has at least 10 other 510(k) clearances on record.