Lyon, France-based Medicrea filed its 510(k) submission to the FDA for its 3-D-printed titanium spinal interbody devices.
Here are four insights:
1. Medicrea executives expect FDA clearance for the devices before year's end.
2. The 3-D printed titanium devices are compatible with the company's UNiD Lab surgical planning technology.
3. The UNiD Lab services help a surgeon create 3D-printed interbody anatomical specifications as well as offer a predictive analysis of global spinal parameters.
4. By the end of 2016, surgeons had used the UNiD Rod technology in more than 1,110 procedures. The FDA cleared the technology in late 2014.