CoRoent Small Interbody Cleared for Cervical Disc Degeneration at up to 4 Levels

By Julie A. Vetalice

NuVasive received FDA 510(k) clearance to market the CoRoent® Small Interbody™ System for intervertebral body fusion at multiple contiguous levels in the cervical spine. This marks the first U.S. clearance for a cervical cage to be used at up to four contiguous levels.

Implants included in the clearance are CoRoent Small, Small Lordotic (SL), Small Lordotic Plus (SLP), Small Hyperlordotic (SHL) and CoRoent Small Contoured (SC).

The system comprises a PEEK-Optima-based interbody cage for stabilization of the spinal motion segment. A hollow core is filled with autogenous and/or allogeneic bone graft to help promote fusion. Rows of teeth on the surface of each end of the device grip adjacent vertebrae to resist migration and expulsion, and the device includes titanium alloy or tantalum marker pins.

Sources: NuVasive, Inc.; ORTHOWORLD Inc.

 

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory