Woven Orthopedic Technologies LLC secured a second U.S. FDA 510(k) clearance for the use of its Ogmend implant enhancement system in spine surgery. The approval is for the large size Ogmend sleeve which is compatible with pedicle screws up to 10.5 mm and will give surgeons a tool to be able to easily secure stable fixation between the screw and bone during orthopedic surgery.
Woven Orthopedic Technologies LLC, received U.S. FDA 510(k) clearance for its Ogmend implant enhancement system for use in spine surgery. Ogmend is expected to give surgeons more confidence in using surgical screws when operating in compromised fixation scenarios.