Recognized standard
F1541-24
FDA recognition 11-428 · ASTM · Orthopedic
Key facts
| Recognition number | 11-428 |
|---|---|
| Designation | F1541-24 |
| Title | Standard Specification and Test Methods for External Skeletal 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 provides a characterization of the design and mechanical function of external skeletal fixation devices (ESFDs), test methods for characterization of ESFD mechanical properties, and identifies needs for further development of test methods and performance criteria. The ultimate… |
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: