510(k) Clearance of 3D-Printed Digital Fusion Implant (press release)
website... http://www.additiveortho.com/
Additive Orthopaedics, LLC, an early stage orthopedic device company, has received FDA 510(k) clearance for its 3D-printed titanium digital fusion implant, to address the over 1.1 million U.S. fusion procedures annually.
"Additive manufacturing allows us to develop complex geometries at reasonable manufacturing costs not possible before now with traditional manufacturing," said Greg Kowalczyk, president and founder of Additive Orthopaedics. "Design teams really need to think outside t...