SurGenTec Receives the US FDA Clearance for ION-C Facet Fixation System
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 & lordosis
- ION-C Facet Fixation System is bilaterally implanted within facet joints & combines a zero-profile implant with a sterile, single-use instrumentation kit, enabling controlled, non-impact insertion with in-situ depth adjustment
Ref: Businesswire | Image: SurGenTec | Press Release
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