Orthofix, Inc. - FDA 510(k) Cleared Devices
57
Total
57
Cleared
0
Denied
55 devices
Cleared
Dec 16, 2016
CETRA Anterior Cervical Plate System
Orthopedic
85d
Cleared
Sep 08, 2016
PILLAR SA PTC
Orthopedic
140d
Cleared
Jun 17, 2016
Cervical Stand Alone System
Orthopedic
42d
Cleared
Jan 29, 2016
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System
Orthopedic
65d
Cleared
Jan 14, 2016
FORZA PTC Spacer System
Orthopedic
136d
Cleared
Sep 11, 2015
CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System
Orthopedic
185d
Cleared
Jul 07, 2015
Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System
Orthopedic
35d
Cleared
May 29, 2015
Azure Anterior Cervical Plate System
Orthopedic
220d
Cleared
May 15, 2015
Centurion POCT System
Orthopedic
49d
Cleared
Jan 08, 2015
CONSTRUX MINI PEEK
Orthopedic
155d
Cleared
Jan 02, 2015
FIREBIRD SPINAL FIXATION SYSTEM
Orthopedic
240d
Cleared
Jul 02, 2014
SKYHAWK LATERAL PLATE SYSTEM
Orthopedic
149d
Cleared
May 27, 2014
SKYHAWK INTERBODY FUSION SYSTEM
Orthopedic
67d
Cleared
Apr 14, 2014
CERVICAL STAND ALONE SYSTEM
Orthopedic
202d
Cleared
Jan 30, 2014
CENTURION POCT SYSTEM
Orthopedic
224d
Cleared
Aug 07, 2013
FIREBIRD SPINAL FIXATION SYSTEM
Orthopedic
125d
Cleared
May 07, 2013
AZURE ANTERIOR CERVICAL PLATE SYSTEM
Orthopedic
42d
Cleared
Jul 20, 2012
ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM)
Orthopedic
45d
Cleared
Feb 16, 2012
ICON (TM) MODULAR PEDICLE SCREW SYSTEM
Orthopedic
268d
Cleared
Jun 21, 2011
GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)
Orthopedic
90d
Cleared
May 24, 2011
ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME...
Orthopedic
27d
Cleared
Mar 23, 2011
FORZA SPACER SYSTEM
Orthopedic
153d
Cleared
Dec 15, 2010
CONTOURS LAPIDUS PLATING SYSTEM
Orthopedic
133d
Cleared
Oct 20, 2010
CONTOURS VSP III VOLAR PLATING SYSTEM
Orthopedic
100d
Cleared
Sep 27, 2010
CONSTRUX MINI PEEK SPACER SYSTEM
Orthopedic
90d