Recognized standard
F2077-24
FDA recognition 11-421 · ASTM · Orthopedic
Key facts
| Recognition number | 11-421 |
|---|---|
| Designation | F2077-24 |
| Title | Standard Test Methods for Intervertebral Body Fusion Devices |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | May 26, 2025 |
| 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
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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: