Orthopedic surgery navigation and positioning system approved for listing
November 28, 2016 Source: cfda
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];On November 14, 2016, the State Food and Drug Administration reviewed and approved the medical device registration of the orthopedic surgery navigation and positioning system (model: TiRobot) of Beijing Tianzhihang Medical Technology Co., Ltd.
The device consists of a host, robotic arm, surgical planning and control software, optical tracking system, master trolley and navigation and positioning kit for robotic assisted surgical instruments in open or percutaneous surgery in spinal surgery and traumatic orthopedics. Or the positioning of the implant.
The orthopedic surgery navigation and positioning system adopts 6-degree-of-freedom manipulator, compatible 2D and 3D medical imaging and other patented technologies. The performance indexes reach the international level of similar products, and are suitable for the use of traumatic orthopedics with cannulated screw internal fixation and spinal screw internal fixation. The patient can effectively ensure the accuracy of screw placement, shorten the operation time, reduce X-ray radiation damage, and reduce patient damage.
The State Food and Drug Administration encourages the support for the innovation and development of the medical device industry, further strengthens the examination of innovative medical devices, strengthens the quality supervision after the products are put on the market, promotes the healthy and orderly development of the medical device industry, and safeguards the safety of the public.
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