Recognized standard
F3437-23
FDA recognition 11-439 · ASTM · Orthopedic
Key facts
| Recognition number | 11-439 |
|---|---|
| Designation | F3437-23 |
| Title | Standard Test Methods for Metallic Bone Plates Used in Small Bone Fracture Fixation |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This standard is intended to provide guidance for the static testing of small bone metallic plates used for fracture fixation. Small bone plates referred to in this standard would be used in minimally load-bearing anatomical areas of the far extremities, such as the fingers and toes, and in the… |
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: