ASTM F2077: Testing Intervertebral Body Fusion Devices
An in-depth look at testing spinal devices according to the ASTM F2077 standard and other industry guidance.
ASTM F2077 is the standard specification for testing intervertebral body fusion devices, including guidelines for both static and dynamic testing. The method specifies the use of compression, compression-shear, and torsion testing to gain information about the mechanical properties of intervertebral spinal implants.
Testing intervertebral body fusion devices per ASTM F2077 is a significant investment for a company, so proper preparation and guidance is crucial. In addition to ASTM F2077, there are different FDA guidance documents used as a reference for testing and inspection. Our medical device testing experts can assist in determining the best test methods for bringing your device to market quickly and safely.
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This article outlines the test methods, results, acceptance criteria, and common pitfalls of testing intervertebral body fusion devices.