Centinel Spine said yesterday it won Australian Therapeutic Goods Administration clearance for its Stalif L no-profile lateral lumbar integrated interbody system.
Centinel Spine touts the Stalif L as the only lateral device to offer a no-profile, compressive lag fixation device with proprietary anti-backout technology and 12-degrees of lordosis, as well as a large chamber for bone graft to support fusion.
“This clearance expands our International No-Profile, Integrated Interbody market. Stalif has enjoyed a long successful history in Australia and now Stalif L exemplifies our continued commitment to being the gold standard in Integrated Interbody devices. We are excited to bring the Stalif advantage to minimally-invasive spinal fusion surgery in Australia,” CEO John Viscogliosi said in a press release.
“Orthotech is proud to represent Centinel Spine in Australia. We are excited to receive the Stalif L clearance enabling us to provide this innovative technology to our surgeon customers and their spine surgery patients. The entire Stalif product portfolio, including the new Stalif L, and the Ti-Active technology, a texturized, titanium coating, allows our surgeon customers to offer their patients the most up-to-date spinal technologies with a heritage of more than 25 years of proven clinical success as a treatment for degenerative spinal pathologies,” Orthotech Orthopaedics Holdings managing director Sam Scott-Young said in a prepared statement.
In January, Centinel Spine said it won FDA 510(k) clearance for its Altos posterior cervical thoracic stabilization system with indications for use in lateral masses of the cervical spine or pedicles of the cervical-thoracic spine.
The West Chester, Penn.-based company said the 1st surgical implantation of the system was performed earlier this month at Las Vegas’ Western Regional Center for Brain & Spine Surgery.