Recognized standard
F2580-18
FDA recognition 11-344 · ASTM · Orthopedic
Key facts
| Recognition number | 11-344 |
|---|---|
| Designation | F2580-18 |
| Title | Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | 1.1 This practice covers a procedure for the fatigue testing of metallic femoral hip prostheses used in hip joint replacements. This practice covers the procedures for the performance of fatigue tests on metallic femoral hip stems using a cyclic, constant-amplitude force. It applies to hip… |
At a glance
- 10–99 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: