Business & Finance
FDA Grants 510(k) Clearance to NuVasive for Redesigned Scoliosis Treatment Technology
7 September 2017 - - San Diego, California-based spinal surgery products developer NuVasive, Inc. (NASDAQ: NUVA), has received 510(k) clearance from the US Food and Drug Administration for use of the company's redesigned MAGEC system with its RELINE Small Stature system, the company said.
The MAGEC system uses innovative magnetic technology within adjustable growing rods to treat early-onset scoliosis in a less invasive manner.
The latest advancements to the MAGEC system include redesigned components to help provide ease-of-use for the surgeon and help make surgical outcomes more reproducible.
In addition, the MAGEC system is introducing a new 5.0 millimeter rod diameter offering, that when paired with the low-profile RELINE Small Stature system, is designed to provide optimal strength to growing-rod constructs to help improve clinical outcomes.
RELINE Small Stature is a comprehensive pediatric deformity fixation system allowing to achieve optimal construct strength with a reduced implant profile. RELINE Small Stature is the only small stature system that is compatible with the new 5mm MAGEC rod.
NuVasive develops minimally invasive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The company's portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With USD 962m in revenues, NuVasive has an approximate 2,300 person workforce in more than 40 countries.