Medical Device Manufacturer · US , Cleveland , OH

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

25 submissions · 25 cleared · Since 2005

Recent clearances: INTRAOSSEOUS FIXATION SYSTEM, ORTHOHELIX STAPLE SYSTEM, MAXLOCK EXTREME ELBOW FRACTURE SYSTEM

25
Total
25
Cleared
0
Denied

FDA 510(k) Regulatory Record - Orthohelix Surgical Designs, Inc. Orthopedic ✕

25 devices
1-12 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
Filters
Filter by Specialty
All25 Orthopedic 25