Recognized standard
F2077-18
FDA recognition 11-347 · ASTM · Orthopedic
Key facts
| Recognition number | 11-347 |
|---|---|
| Designation | F2077-18 |
| Title | Test Methods for Intervertebral Body Fusion Devices |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This test method covers the materials and methods for the static and dynamic testing of intervertebral body fusion device assemblies, spinal implants designed to promote arthrodesis at a given spinal motion segment. 1.2 This test method is intended to provide a basis for the mechanical… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
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About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: