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QUARTEX constructs may be connected to stabilization systems including ELLIPSE PROTEX CT PROTEX CREO REVERE or BEACON Systems using corresponding connectors. Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled sMisbranding by reference to premarket notifications 21 CFR Part 807. Performance Data Performance of the QUARTEX Occipito-Cervico-Thoracic Spinal System was evaluated in accordance with ASTM F1717 ASTM F2706 and the Guidance for...
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