The static and dynamic fatigue tests of the spinal fusion system require an all-electric drive servo fatigue tester or a hydraulic servo fatigue tester, such as the TestResources TR830 or TR810 all-electric fatigue tester or the TR910 hydraulic fatigue tester.
The FDA2004 guidelines document applies to fusion vertebral systems for plates and rods, as well as vertebral body replacement devices. The spine system of each rod and plate foundation is described by one or more systems (eg, thoracolumbar anterior plate system and pedicle screw system).
This guidance document does not focus on intervertebral fusion and non-fusion devices (stent or disc replacement devices) or other non-fixed spinal devices.
The static and dynamic fatigue tests of the spinal fusion system require an all-electric drive servo fatigue tester or a hydraulic servo fatigue tester, such as the TestResources TR830 or TR810 all-electric fatigue tester or the TR910 hydraulic fatigue tester.
Summary of Spinal Implant Mechanics Test: The FDA recommends using the final version to consider the worst-case spinal component system for testing. The components being tested should contain the worst-case conditions such as structural design, interconnection mechanisms, materials, and manufacturing processes. The test should include the worst case construction involving the entire system, unless there are good reasons to test only the individual components.
Cervical spine system test, system type test. Pre-neck system:


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