The FDA has issued a total of 14 orthopedic de novos, eight of which were for clients of MCRA, according to a May 9 press release from the company.
MCRA also had a hand in the first ever orthopedic de novo, granted in 2017 for IlluminOss Medical.
MCRA helps medical device companies with research, compliance, reimbursement, quality insurance and more from conception to commercialization.
At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 11-13 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.
