Foundation Surgical earned FDA 510(k) clearance for its Interwedge standalone lateral interbody system.
Three things to know:
1. The device can be used in conjunction with the company's LLIF 180 procedure, according to an Oct. 4 news release. The LLIF 180 procedure is a bilateral-fixated standalone-lateral procedure.
2. The Interwedge's deployable system makes the LLIF 180 procedure possible and is designed to provide ipsilateral and contralateral fixation.
3. The device and procedure help facilitate a lumbar spinal fusion without the need for supplemental posterior fixation.