Recognized standard
F2068-15
FDA recognition 11-299 · ASTM · Orthopedic
Key facts
| Recognition number | 11-299 |
|---|---|
| Designation | F2068-15 |
| Title | Standard Specification for Femoral Prostheses - Metallic Implants |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Apr 4, 2016 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | 1.1 This specification covers metallic stemmed femoral prostheses used to replace the natural hip joint by means of hemi-arthroplasty or total hip surgical procedures. Prostheses for hemi-arthroplasty are intended to articulate with the natural acetabulum of the patient. Prostheses for total 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: