NuVasive wins 1st FDA nod for CoRoent multi-level cervical implant

NuVasive Inc. (NSDQ:NUVA) said today that the FDA granted 510(k) clearance for its CoRoent small interbody implant for fusion procedures in the cervical spine, claiming it as the 1st U.S. nod for a cervical cage used at up to 4 levels.
The CoRoent device is an interbody cage made of PEEK-Optima polymer, designed to stabilize the cervical spinal during fusion. It’s hollow to allow autogenous and/or allogeneic bone grafts to be inserted. The FDA clearance covers the CoRoent small, small lordotic, small lordotic plus, small hyperlordotic and small contoured implants, San Diego-based NuVasive said.
“This FDA 510(k) clearance is another key milestone for NuVasive as we continue to deliver new innovation to the spine market. The ability to treat multi-level cervical disc degeneration in patients displaying cervical radiculopathy and myelopathy is a meaningful advancement for spine surgeons,” president & CEO Jason Hannon said in prepared remarks. “This 1st and only clearance is an example of NuVasive’s commitment to defining the components necessary to properly address an unmet clinical need and expand our presence and competitive positioning in the cervical market.”
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Source: Mass Device - March 29, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Spinal Nuvasive Source Type: news