Xēnix Medical earned FDA 510(k) clearance for its NeoWave interbody system, the devicemaker said Oct. 10.
The NeoWave portfolio uses the company's Nanoactiv surface tecnology and is designed for cervical and lumbar innterbody spinal fusions, according to a news release. More than 7,000 devices have been implanted in the U.S.
"Receiving nanotechnology clearance for the neoWave interbody systems is an incredible milestone and achievement for Xēnix, elevating the neoWave implant systems into a distinct device category shared only by a few companies in the industry," Xēnix Medical CEO Ryan Phillips said in the release.