VySpine Gets 510(k) Clearance for Its ClariVy Cervical IBF System

VySpine has received 510(k) clearance from the FDA for its ClariVy cervical interbody fusion (IBF) system for use in anterior cervical discectomy procedures.

The implant system, which is made from the organic polymer PEEK (polyetheretherketone), includes sizes ranging from 4 to 11 millimeters. It is available in a variety of lordosis angles to adjust for the inward curvature of the upper spine. The system also features self-drilling screws to anchor the device directly to the bone.

VySpine said it plans a series of product launches for interbody fusion systems in 2022.