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Orthohelix Surgical Designs, Inc.

FDA 510(k) & PMA Approved Devices — 21 products

Total Devices21
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K132591 MAXLOCK EXTREME SYSTEMHRS2013-09-17 View
510(k) K130832 ORTHOHELIX STAPLE SYSTEMJDR2013-08-15 View
510(k) K131324 MAXTORQUE SCREW SYSTEMHWC2013-05-31 View
510(k) K123203 MAXLOCK EXTREME SYSTEM MODEL MXLHRS2012-12-14 View
510(k) K122005 MAXLOCK EXTREME SYSTEMHRS2012-09-06 View
510(k) K121437 MINI MAXLOCK EXTREME PLATING SYSTEMHRS2012-06-13 View
510(k) K120165 INTRAOSSEOUS FIXATION SYSTEMHTY2012-04-17 View
510(k) K120157 MINI MAXLOCK EXTREME PLATING SYSTEMHRS2012-04-10 View
510(k) K113048 MAXLOCK EXTREME SYSTEMHRS2012-01-30 View
510(k) K111041 MINI VARIABLE SYSTEMHRS2011-06-06 View
510(k) K102156 MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWSHRS2010-09-30 View
510(k) K101962 MINI MAXLOCK EXTREME PLATING SYSTEMHRS2010-09-27 View
510(k) K100618 MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGYHRS2010-04-20 View
510(k) K093900 EDGELOCKHRS2010-02-17 View
510(k) K090289 CLAVICLE PLATING SYSTEMHRS2009-06-15 View
510(k) K082574 MAXTORQUE MINI CANNULATED SCREW SYSTEMHWC2008-12-08 View
510(k) K073624 MODULAR FOOT SYSTEMHRS2008-03-20 View
510(k) K061400 CALCANEAL TRAUMA SYSTEMHRS2006-06-29 View
510(k) K060428 CSS CANNULATED SCREW SYSTEMHWC2006-03-07 View
510(k) K053182 DRLOCK DISTAL RADIUS VOLAR SYSTEMHRS2006-02-27 View
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