Orthohelix Surgical Designs, Inc. - FDA 510(k) Cleared Devices
25
Total
25
Cleared
0
Denied
25 devices
Cleared
Aug 21, 2014
INTRAOSSEOUS FIXATION SYSTEM
Orthopedic
125d
Cleared
Aug 21, 2014
ORTHOHELIX STAPLE SYSTEM
Orthopedic
16d
Cleared
Jul 11, 2014
MAXLOCK EXTREME ELBOW FRACTURE SYSTEM
Orthopedic
53d
Cleared
Jan 03, 2014
ORTHOHELIX SYNDESMOSIS FIXATION DEVICES
Orthopedic
122d
Cleared
Sep 17, 2013
MAXLOCK EXTREME SYSTEM
Orthopedic
29d
Cleared
Aug 15, 2013
ORTHOHELIX STAPLE SYSTEM
Orthopedic
142d
Cleared
May 31, 2013
MAXTORQUE SCREW SYSTEM
Orthopedic
23d
Cleared
Dec 14, 2012
MAXLOCK EXTREME SYSTEM MODEL MXL
Orthopedic
63d
Cleared
Sep 06, 2012
MAXLOCK EXTREME SYSTEM
Orthopedic
59d
Cleared
Jun 13, 2012
MINI MAXLOCK EXTREME PLATING SYSTEM
Orthopedic
29d
Cleared
Apr 17, 2012
INTRAOSSEOUS FIXATION SYSTEM
Orthopedic
89d
Cleared
Apr 10, 2012
MINI MAXLOCK EXTREME PLATING SYSTEM
Orthopedic
83d
Cleared
Jan 30, 2012
MAXLOCK EXTREME SYSTEM
Orthopedic
110d
Cleared
Jun 06, 2011
MINI VARIABLE SYSTEM
Orthopedic
53d
Cleared
Sep 30, 2010
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS
Orthopedic
62d
Cleared
Sep 27, 2010
MINI MAXLOCK EXTREME PLATING SYSTEM
Orthopedic
76d
Cleared
Apr 20, 2010
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY
Orthopedic
47d
Cleared
Feb 17, 2010
EDGELOCK
Orthopedic
61d
Cleared
Jun 15, 2009
CLAVICLE PLATING SYSTEM
Orthopedic
130d
Cleared
Dec 08, 2008
MAXTORQUE MINI CANNULATED SCREW SYSTEM
Orthopedic
94d
Cleared
Mar 20, 2008
MODULAR FOOT SYSTEM
Orthopedic
85d
Cleared
Jun 29, 2006
CALCANEAL TRAUMA SYSTEM
Orthopedic
41d
Cleared
Mar 07, 2006
CSS CANNULATED SCREW SYSTEM
Orthopedic
14d
Cleared
Feb 27, 2006
DRLOCK DISTAL RADIUS VOLAR SYSTEM
Orthopedic
105d
Cleared
May 27, 2005
MAXLOCK
Orthopedic
51d