SurGenTec earned FDA 510(k) clearance of its ION-C facet fixation system, according to a Jan. 20 news release.
ION-C is designed for posterior cervical fusion, and the clearance includes indications for the treatment of cervical pseudoarthrosis when implanted bilaterally within the facet joints.
The clearance was built on an IRB-approved study that affirmed the safety and efficacy of ION-C when implanted bilaterally within the facet joints. Long-term outcomes found no adverse events, implant migration or revision surgeries.
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