The FDA awarded SpineEX's Sagittae Lateral Lumbar Interbody Fusion System an additional 510(k) clearance to allow for full-scale commercialization.
What you should know:
1. The new clearance covers new system instrumentation and an updated surgical technique.
2. The FDA initially cleared the device in October 2018.
3. SpineEX expects to begin offering the Sagittae system commercially by the end of March.
4. SpineEX CEO and Chairman Roy Chin said, "We expect, in the very near future, to announce the first procedure using our innovative Sagittae device to be performed by a leading orthopedic surgeon and complete our transition from a development stage to a commercial stage and revenue generating company."