VySpine has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its ClariVy cervical interbody fusion (IBF) system which is designed for use in anterior cervical discectomy with fusion (ACDF) procedures.
Tom McLeer, CEO of VySpine, said: “The ClariVy cervical IBF system is the first in a series of differentiated interbody systems being developed by VySpine. Using new materials and creative surgeon input, we are building exceptional quality, flexibility, and pricing into all our products. This is the just the next step in a series of exciting, innovative product launches scheduled for 2022.”
The system features cervical interbody fusion devices made from either polyetheretherketone (PEEK) Optima LT1, or PEEK Optima HA-Enhanced. It is offered in numerous footprints and heights, ranging from 4mm to 11mm and available either with or without locking screws. Additionally, the ClariVy implants are available in a range of lordosis.