FDA clears world’s first patient-specific spinal rod
The MEDICREA group, a company that specializes in the development of personalized implants produced for a patient’s specific need in the treatment of spinal pathologies, has announced the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for UNiDTM, the world’s first patient-specific spinal osteosynthesis rod. The technology will be premiered at the 2014 North American Spine Society (NASS) Annual Meeting taking place on November 12-15 in San Francisco. The first U.S. patient underwent surgery to have personalized UNiDTM rods implanted earlier today in New York.
Source: Medical News Today