Recognized standard
F2091-15
FDA recognition 11-301 · ASTM · Orthopedic
Key facts
| Recognition number | 11-301 |
|---|---|
| Designation | F2091-15 |
| Title | Standard Specification for Acetabular Prostheses |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Apr 4, 2016 |
| Scope (excerpt) | 1.1 This specification covers acetabular resurfacing devices used to provide a functioning articulation between the bones of the acetabulum and the femur. 1.2 This specification is intended to provide basic descriptions of materials and device geometry. Additionally, those characteristics determined… |
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: