FDA 510(k) Applications Submitted by ORTHOHELIX SURGICAL DESIGNS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K130832 |
03/26/2013 |
ORTHOHELIX STAPLE SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K141004 |
04/18/2014 |
INTRAOSSEOUS FIXATION SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K131324 |
05/08/2013 |
MAXTORQUE SCREW SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K141301 |
05/19/2014 |
MAXLOCK EXTREME ELBOW FRACTURE SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K142148 |
08/05/2014 |
ORTHOHELIX STAPLE SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K132733 |
09/03/2013 |
ORTHOHELIX SYNDESMOSIS FIXATION DEVICES |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K120157 |
01/18/2012 |
MINI MAXLOCK EXTREME PLATING SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K120165 |
01/19/2012 |
INTRAOSSEOUS FIXATION SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K090289 |
02/05/2009 |
CLAVICLE PLATING SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K100618 |
03/04/2010 |
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K111041 |
04/14/2011 |
MINI VARIABLE SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K121437 |
05/15/2012 |
MINI MAXLOCK EXTREME PLATING SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K122005 |
07/09/2012 |
MAXLOCK EXTREME SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K101962 |
07/13/2010 |
MINI MAXLOCK EXTREME PLATING SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K102156 |
07/30/2010 |
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K132591 |
08/19/2013 |
MAXLOCK EXTREME SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K082574 |
09/05/2008 |
MAXTORQUE MINI CANNULATED SCREW SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K113048 |
10/12/2011 |
MAXLOCK EXTREME SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K123203 |
10/12/2012 |
MAXLOCK EXTREME SYSTEM MODEL MXL |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K093900 |
12/18/2009 |
EDGELOCK |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K073624 |
12/26/2007 |
MODULAR FOOT SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K050868 |
04/06/2005 |
MAXLOCK |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K053182 |
11/14/2005 |
DRLOCK DISTAL RADIUS VOLAR SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K060428 |
02/21/2006 |
CSS CANNULATED SCREW SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
| K061400 |
05/19/2006 |
CALCANEAL TRAUMA SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
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