Recognized standard
F1264-24
FDA recognition 11-427 · ASTM · Orthopedic
Key facts
| Recognition number | 11-427 |
|---|---|
| Designation | F1264-24 |
| Title | Standard Specification and Test Methods for Intramedullary Fixation Devices |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This specification is intended to provide a characterization of the design and mechanical function of intramedullary fixation devices (IMFDs), specify labeling and material requirements, provide test methods for characterization of IMFD mechanical properties, and identify needs for further… |
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: