510(k) K083792

WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055 by Medshape Solutions — Product Code HWC

K083792 is an FDA 510(k) premarket notification submitted by Medshape Solutions for the device "WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055". The FDA issued a decision of Substantially Equivalent on March 25, 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.