Recognized standard
F1672-14 (Reapproved 2019)
FDA recognition 11-281 · ASTM · Orthopedic
Key facts
| Recognition number | 11-281 |
|---|---|
| Designation | F1672-14 (Reapproved 2019) |
| Title | Standard Specification for Resurfacing Patellar Prosthesis |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Jan 27, 2015 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | 1.1 This specification covers patellar resurfacing devices used to provide a functioning articulation between the patella and the femur. 1.2 This specification is intended to provide basic descriptions of material and device geometry. Additionally, those characteristics determined to be important to… |
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: