VySpine Gains FDA Clearance for ClariVy Cervical IBF System

By Julie A. Vetalice

VySpine Gains FDA Clearance for ClariVy Cervical IBF System

VySpine received FDA 510(k) clearance to market the ClariVy Cervical IBF (interbody fusion) spinal system, designed for use in anterior cervical discectomy with fusion.

ClariVy Cervical IBF devices are made from either PEEK Optima LT1 or PEEK Optima HA-Enhanced. PEEK Optima LT1 has been the standard for interbody devices for decades, featuring radiolucency and a modulus of elasticity close to that of natural bone. PEEK Optima HA-Enhanced has embedded Hydroxyapatite fibers to create better bony apposition to the implant.

The ClariVy Cervical IBF System is offered in 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.

ClariVy Cervical IBF also features IBF-S implants, which have self-drilling screws to aid in anchoring the device directly to the bone. These screws are self-locking to ensure quick and easy fixation.

VySpine announced FDA 510(k) clearance for its first product, the VySpan Posterior Cervical Thoracic System, earlier this year.

Source: VySpine

Product Labels: Cervical Spine, Spinal Fusion

Tags: 510(k) Clearance, Regulatory