Shots:
The US FDA has granted clearance to SurGenTec's ION-L Lumbar Facet Fixation System for the treatment of skeletally mature pts with degenerative disc disease (DDD) from L3 to S1 who have failed conservative care
Clearance is supported by a multicenter, IRB-approved clinical study in a high-risk, real-world patient population, with independent radiographic reviews confirming…
Shots:
The US FDA has granted clearance to ION-C Facet Fixation System, part of SurGenTec’s posterior cervical platform, for the treatment of cervical pseudoarthrosis
Clearance was supported by IRB-approved long-term study data showing bridging bone across facet joints with no reported AEs, implant migration, or revision surgeries, & postoperative imaging confirming preserved cervical alignment &…

