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Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807. D. Vice President of R D 9930 Mesa Rim Road San Diego California 92121 October 21 2016 Re K160313 Trade/Device Name Xenco Medical Cervical Interbody System Regulation Number 21 CFR 888. Xenco Medical Cervical Interbody System constructs are to be packed with autogenous bone graft and implanted via an open anterior approach....
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