Recognized standard
F2887-17
FDA recognition 11-321 · ASTM · Orthopedic
Key facts
| Recognition number | 11-321 |
|---|---|
| Designation | F2887-17 |
| Title | Standard Specification for Total Elbow Prostheses |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Aug 21, 2017 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | 1.1 This specification covers total elbow replacement (TER) prostheses and hemi-elbow replacement ("hemi") prostheses used to provide functioning articulation by employing humeral, ulnar, and/or radial components that allow for the restoration of motion of the human elbow joint complex. 1.2 Included… |
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: