NuVasive Inc. (NSDQ:NUVA) said today it won FDA 510(k) clearance for its redesigned Magec magnetically controlled growth modulation system.
The San Diego, Calif.-based company’s Magec system uses magnetic technology and adjustable growth rods to treat early-onset scoliosis, and features the company’s Reline small stature system.
The Reline small stature platform is a pediatric deformity fixation system which is designed to improve construct strength and reduce the systems implant profile.
“As a low-profile pediatric fixation system, Reline Small Stature is the first-of-its-kind system to offer competitively-sized pediatric implants that accept up to a 5.0mm rod. The clearance for our redesigned Magec system with Reline small stature highlights our speed to market and our further commitment to bringing procedural solutions that transform care to the pediatric deformity market,” strategy, tech & corporate dev exec VP Matt Link said in a press release.
Last October, NuVasive said it won expanded FDA clearance for its Magec system, now indicated for safe use with 1.5 tesla magnetic resonance imaging devices.