NuVasive Gains Additional FDA Clearance for CoRoent Small Interlock

By Julie A. Vetalice

NuVasive received FDA 510(k) clearance for expanded indications for the CoRoent Small Interlock™ system, allowing for on-label use of the device at multiple contiguous levels from C2 to T1 for anterior cervical discectomy and fusion. This is an alternative to other systems on the market cleared for only one- or two-level use.

CoRoent Small Interlock is a no-profile interfixated device that is implanted entirely within the confines of the vertebral disc space and features a zero-step locking mechanism, a large fusion aperture, angled instrumentation for implantation in difficult anatomical locations and a three-screw implant design allowing for versatile interbody placement.

"The multi-level clearance provides surgeons a zero-profile interbody implant that can be used in more than two contiguous levels, enabling the surgeon to avoid supplemental fixation which can ultimately reduce operative time," said Leonel Hunt, an orthopedic spine surgeon at Hunt Spine in Los Angeles, California.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory