SurGenTec Wins the US FDA Clearance for ION-L to Treat Degenerative Disc Disease
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 fusion outcomes & no reported adverse events
- ION-L is a posterior lumbar facet fixation system designed to minimize surgical footprint, using bilateral placement & controlled non-impact insertion to protect surrounding anatomy while reducing the need for extensive posterior exposure
Ref: Businesswire | Image: SurGenTec | Press Release
Related News: SurGenTec Receives the US FDA Clearance for ION-C Facet Fixation System
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