VySpine announced today that it received FDA 510(k) clearance for its LumiVy NanoVy TI lumbar intervertebral body fusion (IBF) system. Tallahassee, Florida–based VySpine designed the system for IBF at either one level or two contiguous levels in the lumbar spine. It goes between L2 to S1 for the treatment of degenerative disc disease (DDD) with […]
VySpine
FDA clears VySpine’s VyPlate anterior cervical plate system
VySpine this week announced it received FDA 510(k) clearance for its VyPlate anterior cervical plate system. Tallahassee, Florida-based VySpine designed VyPlate to stabilize the anterior cervical spine from C2 to C7 by using unicortical screw fixation at the anterior face the vertebral bodies. The system has plates and screws that are manufactured from titanium alloy […]
FDA clears VySpine’s LumiVy lumbar IBF system
VySpine (Tallahassee, Florida) said today that FDA has granted a 510(k) clearance for its LumiVy lumbar IBF system, designed for use after lumbar discectomy in fusion procedures. The LumiVy system features lumbar interbody fusion devices made from either PEEK Optima LT1 or PEEK Optima HA-enhanced. “The LumiVy Lumbar IBF System is our latest innovation in […]
FDA clears VySpine’s interbody fusion system
VySpine announced today that it received FDA 510(k) clearance for its ClariVy cervical interbody fusion (IBF) system. Tallahassee, Florida-based VySpine designed its ClariVy cervical IBF system for use in anterior cervical discectomy with fusion (ACDF) procedures. According to a news release, the ClariVy system includes cervical interbody fusion devices made from either PEEK Optima LT1 […]