Orthohelix Surgical Designs, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Orthohelix Surgical Designs, Inc. - FDA 510(k) Cleared Devices
25
Total
25
Cleared
0
Denied
Orthohelix Surgical Designs, Inc. has 25 FDA 510(k) cleared orthopedic devices. Based in Cleveland, US.
Historical record: 25 cleared submissions from 2005 to 2014.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Orthohelix Surgical Designs, Inc.
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