Recognized standard
F3574-25
FDA recognition 11-446 · ASTM · Orthopedic
Key facts
| Recognition number | 11-446 |
|---|---|
| Designation | F3574-25 |
| Title | Standard Test Methods for Sacroiliac Joint Fusion Devices |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | May 25, 2026 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 These test methods cover the materials and methods for the static and dynamic testing of sacroiliac joint (SIJ) fusion device assemblies, SIJ implants designed to promote arthrodesis at the sacroiliac joint. 1.2 These test methods are intended to provide a basis for the mechanical comparison… |
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: