Medical Device Manufacturer · US , Cleveland , OH

Orthohelix Surgical Designs, Inc. - FDA 510(k) Cleared Devices

25 submissions · 25 cleared · Since 2005
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
1-25 of 25
Cleared Aug 21, 2014
INTRAOSSEOUS FIXATION SYSTEM
K141004 · HTY
Orthopedic · 125d
Cleared Aug 21, 2014
ORTHOHELIX STAPLE SYSTEM
K142148 · JDR
Orthopedic · 16d
Cleared Jul 11, 2014
MAXLOCK EXTREME ELBOW FRACTURE SYSTEM
K141301 · HRS
Orthopedic · 53d
Cleared Jan 03, 2014
ORTHOHELIX SYNDESMOSIS FIXATION DEVICES
K132733 · HTN
Orthopedic · 122d
Cleared Sep 17, 2013
MAXLOCK EXTREME SYSTEM
K132591 · HRS
Orthopedic · 29d
Cleared Aug 15, 2013
ORTHOHELIX STAPLE SYSTEM
K130832 · JDR
Orthopedic · 142d
Cleared May 31, 2013
MAXTORQUE SCREW SYSTEM
K131324 · HWC
Orthopedic · 23d
Cleared Dec 14, 2012
MAXLOCK EXTREME SYSTEM MODEL MXL
K123203 · HRS
Orthopedic · 63d
Cleared Sep 06, 2012
MAXLOCK EXTREME SYSTEM
K122005 · HRS
Orthopedic · 59d
Cleared Jun 13, 2012
MINI MAXLOCK EXTREME PLATING SYSTEM
K121437 · HRS
Orthopedic · 29d
Cleared Apr 17, 2012
INTRAOSSEOUS FIXATION SYSTEM
K120165 · HTY
Orthopedic · 89d
Cleared Apr 10, 2012
MINI MAXLOCK EXTREME PLATING SYSTEM
K120157 · HRS
Orthopedic · 83d
Cleared Jan 30, 2012
MAXLOCK EXTREME SYSTEM
K113048 · HRS
Orthopedic · 110d
Cleared Jun 06, 2011
MINI VARIABLE SYSTEM
K111041 · HRS
Orthopedic · 53d
Cleared Sep 30, 2010
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS
K102156 · HRS
Orthopedic · 62d
Cleared Sep 27, 2010
MINI MAXLOCK EXTREME PLATING SYSTEM
K101962 · HRS
Orthopedic · 76d
Cleared Apr 20, 2010
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY
K100618 · HRS
Orthopedic · 47d
Cleared Feb 17, 2010
EDGELOCK
K093900 · HRS
Orthopedic · 61d
Cleared Jun 15, 2009
CLAVICLE PLATING SYSTEM
K090289 · HRS
Orthopedic · 130d
Cleared Dec 08, 2008
MAXTORQUE MINI CANNULATED SCREW SYSTEM
K082574 · HWC
Orthopedic · 94d
Cleared Mar 20, 2008
MODULAR FOOT SYSTEM
K073624 · HRS
Orthopedic · 85d
Cleared Jun 29, 2006
CALCANEAL TRAUMA SYSTEM
K061400 · HRS
Orthopedic · 41d
Cleared Mar 07, 2006
CSS CANNULATED SCREW SYSTEM
K060428 · HWC
Orthopedic · 14d
Cleared Feb 27, 2006
DRLOCK DISTAL RADIUS VOLAR SYSTEM
K053182 · HRS
Orthopedic · 105d
Cleared May 27, 2005
MAXLOCK
K050868 · HRS
Orthopedic · 51d
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