NuVasive Inc. (NSDQ:NUVA) said today that it won 510(k) clearance from the FDA for the Reline posterior fixation system used with its Magec device for treating severe spinal deformities.
The Reline system is designed with an integrated global alignment platform designed to treat patients through open or minimally invasive procedures. Magec is a magnetically controlled growing-rod system cleared by the FDA for treating pediatric spinal deformities, the San Diego, Calif.-based company said.
“The FDA 510(k) clearance is a key milestone for NuVasive as we continue to deliver new innovation to the spine market, and now more specifically, the pediatric deformity market. More importantly, it reflects an increased ability to better treat children with EOS. Combining the game-changing innovation of Magec and the versatility of Reline, we help transform the experience for these young patients. NuVasive is committed to partnering with surgeons to revolutionize deformity surgery for patients in need around the globe,” prez & COO Jason Hannon said in a press release.
In August, NuVasive said the Centers for Medicare and Medicaid Services granted a new technology add-on payment for magnetically controlled growth rods, including the company’s Magec system.
The company touted its Magec system as the only magnetically controlled growth modulation system cleared by the FDA for pediatric spinal deformity. NuVasive acquired the technology when it paid $410 million for Essential Medical this year.
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