Meditech Spine, LLC, announced it has received additional 510(k) clearance for its CURE Lumbar Plating (LP) System from the US Food and Drug Administration (FDA).
Devices for Anterior Lumbar and Lateral Lumbar Fusion Surgeries Receive FDA Clearance
ATLANTA, April 30, 2018 /PRNewswire/ -- Meditech Spine, LLC, announced today it has received additional 510(k) clearance for its CURE Lumbar Plating (LP) System from the US Food and Drug Administration (FDA). The CURE LP iView and Cure LP QMax System clearance compliments Meditech’s recent 510(k) of the CURE Lumbar Plate System in 2017 with additional plating options. The CURE LP allows surgeons to utilize the lumbar plating system along with its novel lumbar Talos® fusion devices, which are manufactured with the PEEK-OPTIMA™ HA Enhanced polymer.
The CURE LP is a low profile titanium plate that incorporates a proprietary, one-step locking mechanism to prevent screws anchored on the spine from loosening and backing out. The special 510(k) includes additional sizing options for surgeons. The CURE LP-iView is similar to the standard CURE LP anterior plate but includes a through hole with rib to nest with the Talos®-A (HA) Interbody Device. And, the CURE LP-QMax is a four hole direct lateral plate complimenting the previously cleared two hole plate. The CURE LP anterior plates, sacral plates and the new iView and Qmax plates will be combined in one tray with streamlined instruments to make it easier on hospital and surgery centers to process the system. All systems will be provided sterile packaged to aid with implant tracking while helping to reduce implant related infections. The CURE Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach.
With the introduction of the CURE Anterior Cervical Plating (ACP) last year, Meditech continues its philosophy of giving back which led to a partnership with CURE International, the namesake of the CURE ACP and CURE LP, an organization that serves children with physical disabilities in underserved areas of the world. A portion of proceeds from the sale of every plate will help CURE International treat patients in underserved areas who are in need of surgical care.
“After the introduction in late 2017 with our CURE LP system, we have continued to listen to surgeons and build upon our existing platform by providing additional plating options. Surgeons now have the flexibility of choosing from multiple plate configurations for their patients that require supplemental fixation. When coupled with our Talos®-A (HA) Interbody Fusion Device, manufactured with our next generation osteoconductive polymer, we provide a full and robust system for surgeons who utilize the anterior and anteriorlateral approaches to treat degenerative spinal conditions,” Eric Flickinger, Co-founder of Meditech Spine, noted.
For more information visit Meditech Spine.
ABOUT MEDITECH SPINE, LLC
Meditech Spine, LLC, is a spinal device company developing innovative instrumentation for treating complex spinal issues. It partners with leaders in the industry to design, develop, and distribute implant devices that make a positive difference in the market. Meditech’s pursuit of novel and innovative technologies drives its design and development team. As Meditech builds on its IP platform, it seeks strategic partnerships and applications to provide surgeons and patients with the best available technologies.
