Alphatec Holdings, the parent company of Alphatec Spine, a medical technology company, has received the FDA 510(k) market clearance for its Novel cervical interbody implant.
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The Novel cervical interbody implant is said to be the latest product in Alphatec Spine’s pipeline that provides solutions for disorders affecting the cervical spine.
The Novel cervical interbody is offered in three footprints in both Peek and titanium. The implant is designed to optimize endplate contact and has windows that increase the surgeon’s ability to insert grafting material into the implant, the company said.
The Novel cervical interbody has been cleared by the FDA as a cervical interbody device, complementing existing Alphatec Spine products, including the Trestle anterior cervical plating system, the Solanas posterior cervico-thoracic fixation system, and the AlphaGRAFT ProFUSE demineralized bone scaffolds.
Dirk Kuyper, president and CEO of Alphatec Spine, said: “We are very pleased to be one of the few companies to have an implant receive FDA clearance as a cervical interbody device. The addition of the new Novel cervical interbody implant to our product portfolio is an extremely positive step in our company’s commitment to bringing a full-line of spinal solutions to the surgeon community.”
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