Woven Orthopedics earned its second FDA 510(k) clearance for the Ogmed implantable sleeve, the company said Feb. 29.
Ogmend is used to help secure stable screw fixation, and the large size version of the implant has clearance, according to a news release. The medium and large versions of Ogmend are available in the U.S. and Europe.
"The large Ogmend provides surgeons with a unique and simple tool for a number of situations where larger size screws are more common, such as longer construct corrections, complex thoracolumbar revisions, and complex spinal deformities," Woven's Commercial Director, Justin Loosvelt, said in the release.