Meditech Spine has received US Food and Drug Administration (FDA) 510(k) clearance to market the CURE Opel-L (S) system, a new lumbar plate option.
The new system expands upon the previously cleared CURE LP plate system and compliments its Talos-A (HA) Interbody system, Meditech Spine said in a press release announcing the approval. Meditech will now offer an interbody/plate assembly for the anterior lumbar spine
The new system has an increased screw angulation and repeatable, more precise A/P alignment with an optional All-in-One drill guide during the placement of the device, the company’s press release added.
Meditech is adding and launching hyper-lordotic sizes to its existing Talos-A (HA) line of osteoconductive PEEK-OPTIMA HA Enhanced ALIF implants.
Meditech continues its relationship with CURE International, the namesake of the CURE ACP, an organisation 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.