Mazor Robotics (NSDQ:MZOR) said today that the China Food & Drug Administration approved its Renaissance system for robot-assisted spine procedures.

Caesarea, Israel-based Mazor said it’s already tapped a Chinese distributor, Beijing-based Cicel, to run seminars and hands-on lab sessions in the U.S. for "China’s leading spine surgeons."

"Receiving CFDA’s approval for marketing the Renaissance system in China is a significant achievement for Mazor, giving us access to a large and growing market opportunity," CEO Ori Hadomi said in prepared remarks. "China continues to adopt proven and state-of-the-art technologies to offer better patient outcomes, so we believe Renaissance is well-positioned to gain market acceptance. Our distribution partner, Cicel, believes the target market for Renaissance is in the hundreds of hospitals in China. Now, with the CFDA approval, our partner will initiate its marketing and sales process to introduce Renaissance to this important market. Cicel has the local market knowledge and expertise along with the sales, marketing and clinical organization to quickly raise awareness of the Renaissance system."

Mazor said it has 7 installed Renaissance systems in India, Hong Kong, Taiwan, Singapore, Vietnam and Australia.

In July, Mazor touted results from a clinical study showing a 99% accuracy rate in screw placement in pediatric scoliosis patients treated with the Renaissance system. Earlier this year the company moved into the neurosurgical suite, announcing a brain module for the Renaissance system.