Meditech Spine said today it has received FDA 510(k) clearance to market the CURE Opel-C Plate spinal implant system, an add-on technology to its already cleared CURE anterior cervical plate (ACP) system and Talos-C hydroxyapatite (HA) interbody systems.
With this approval, Meditech will now offer two additional CURE ACP plating options with its Talos line of cervical interbodies made with the osteoconductive PEEK-Optima HA-enhanced material. Since Meditech introduced its CURE ACP system in late 2016, its adoption and usage have seen double-digit growth, according to a company statement. By adding the Opel-C plating options to the CURE ACP product line, surgeons now have two modular snap-on plate styles providing rigid fixation while minimizing adjacent level impact.
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