FDA 510(k) Applications Submitted by MEDSHAPE SOLUTIONS

FDA 510(k) Number Submission Date Device Name Applicant
K101934 07/12/2010 DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000 MEDSHAPE SOLUTIONS
K091202 04/24/2009 WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS, MEDSHAPE SOLUTIONS
K092914 09/22/2009 WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES MEDSHAPE SOLUTIONS
K083792 12/19/2008 WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055 MEDSHAPE SOLUTIONS
K101808 06/29/2010 SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER MEDSHAPE SOLUTIONS


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