Recognized standard
F3631-24
FDA recognition 11-418 · ASTM · Orthopedic
Key facts
| Recognition number | 11-418 |
|---|---|
| Designation | F3631-24 |
| Title | Standard Test Method for Assessment of Intra-operative Durability of Intervertebral Body Fusion Devices |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This test method covers the materials and methods for impact testing of lumbar intervertebral body fusion devices (IBFD). 1.2 This test method is intended to provide a basis for the mechanical comparison among nonbiologic IBFD assemblies (the IBFD and associated inserter tool). This test method… |
At a glance
- None 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: