FDA 510(k) Applications Submitted by ORTHOFIX, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K130825 |
03/26/2013 |
AZURE ANTERIOR CERVICAL PLATE SYSTEM |
ORTHOFIX, INC. |
| K111448 |
05/24/2011 |
ICON (TM) MODULAR PEDICLE SCREW SYSTEM |
ORTHOFIX, INC. |
| K150822 |
03/27/2015 |
Centurion POCT System |
ORTHOFIX, INC. |
| K130932 |
04/04/2013 |
FIREBIRD SPINAL FIXATION SYSTEM |
ORTHOFIX, INC. |
| K141186 |
05/07/2014 |
FIREBIRD SPINAL FIXATION SYSTEM |
ORTHOFIX, INC. |
| K151488 |
06/02/2015 |
Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System |
Orthofix, Inc. |
| K131833 |
06/20/2013 |
CENTURION POCT SYSTEM |
ORTHOFIX, INC. |
| K970400 |
02/03/1997 |
BONE SOURCE HYDROXYAPATITE |
ORTHOFIX, INC. |
| K031219 |
04/17/2003 |
MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR) |
ORTHOFIX, INC. |
| K101936 |
07/12/2010 |
CONTOURS VSP III VOLAR PLATING SYSTEM |
ORTHOFIX, INC. |
| K142152 |
08/06/2014 |
CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM |
ORTHOFIX, INC. |
| K143028 |
10/21/2014 |
Azure Anterior Cervical Plate System |
ORTHOFIX, INC. |
| K042766 |
10/05/2004 |
ORTHOFIX VOLAR DISTAL RADIAL PLATE |
ORTHOFIX, INC. |
| K961027 |
03/14/1996 |
ORTHOFIX TIBIAL NAILING SYSTEM |
ORTHOFIX, INC. |
| K955848 |
12/27/1995 |
ORTHOFIX MODULSYSTEM |
ORTHOFIX, INC. |
| K200606 |
03/09/2020 |
O-Genesis Graft Delivery System |
Orthofix, Inc. |
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