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Orthohelix Surgical Designs Inc

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
25
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0062-2015Class IIMaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with lSeptember 19, 2014
Z-0975-2013Class IIIntraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabOctober 30, 2012
Z-0027-2013Class IIOrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are January 29, 2010
Z-0026-2013Class IIOrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are January 29, 2010

Recent 510(k) Clearances

K-NumberDeviceDate
K141004INTRAOSSEOUS FIXATION SYSTEMAugust 21, 2014
K142148ORTHOHELIX STAPLE SYSTEMAugust 21, 2014
K141301MAXLOCK EXTREME ELBOW FRACTURE SYSTEMJuly 11, 2014
K132733ORTHOHELIX SYNDESMOSIS FIXATION DEVICESJanuary 3, 2014
K132591MAXLOCK EXTREME SYSTEMSeptember 17, 2013
K130832ORTHOHELIX STAPLE SYSTEMAugust 15, 2013
K131324MAXTORQUE SCREW SYSTEMMay 31, 2013
K123203MAXLOCK EXTREME SYSTEM MODEL MXLDecember 14, 2012
K122005MAXLOCK EXTREME SYSTEMSeptember 6, 2012
K121437MINI MAXLOCK EXTREME PLATING SYSTEMJune 13, 2012
K120165INTRAOSSEOUS FIXATION SYSTEMApril 17, 2012
K120157MINI MAXLOCK EXTREME PLATING SYSTEMApril 10, 2012
K113048MAXLOCK EXTREME SYSTEMJanuary 30, 2012
K111041MINI VARIABLE SYSTEMJune 6, 2011
K102156MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWSSeptember 30, 2010
K101962MINI MAXLOCK EXTREME PLATING SYSTEMSeptember 27, 2010
K100618MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGYApril 20, 2010
K093900EDGELOCKFebruary 17, 2010
K090289CLAVICLE PLATING SYSTEMJune 15, 2009
K082574MAXTORQUE MINI CANNULATED SCREW SYSTEMDecember 8, 2008