Amedica receives FDA 510(k) clearance for new pedicle screw system
Amedica (published 27/11/2007)
The US Food and Drug Administration has granted 510(k) marketing clearance to Amedica's Valeo Pedicle Screw system.
The Valeo Pedicle Screw system is a low profile and modular pedicle screw system incorporating features that are aimed at allowing surgeons greater flexibility in the positioning of these spinal implants.
The Valeo Pedicle Screw system is intended for non-cervical pedicle fixation from the T1 through L5 vertebral bodies of the spine as an adjunct to fusion.
The Implant and related instruments are designed to facilitate greater modularity and to better suit patient anatomy and achieve a consistent supplemental fixation outcome for many indications including degenerative disc disease, spinal stenosis and failed prior spine fusion surgery.
'FDA clearance of our Valeo Pedicle Screw System is another important milestone for Amedica,' said Ashok Khandkar, PhD, chief executive officer of Amedica. 'Our pedicle screw system and recently cleared cervical plate will complement our line of innovative, silicon nitride ceramic spinal spacers, providing surgeons and patients with an important new option for spinal fixation.'
