The design and development of orthopedic implants takes a
significant amount of time, money and labor. According to Randy
Roof, the President, CEO and Founder of Cutting Edge Spine
(CES), it took five years for its proprietary T-FIX 3DSI Joint Fusion
System to attain FDA 510(k) clearance, a triumph the company
celebrated in July.
We recently spoke with Roof on navigating obstacles and
roadblocks in the development of new orthopedic technologies.
He started by providing background on the technology’s origins
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