510(k) K091202

WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS, by Medshape Solutions — Product Code HWC

K091202 is an FDA 510(k) premarket notification submitted by Medshape Solutions for the device "WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS,". The FDA issued a decision of Substantially Equivalent on September 16, 2009. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Medshape Solutions has at least 5 other 510(k) clearances on record.