Recognized standard
F2028-17
FDA recognition 11-330 · ASTM · Orthopedic
Key facts
| Recognition number | 11-330 |
|---|---|
| Designation | F2028-17 |
| Title | Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 21, 2020 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | 1.1 These test methods measure how much a prosthetic anatomic glenoid component rocks or pivots following cyclic displacement of the humeral head to opposing glenoid rims (for example, superior-inferior or anterior-posterior). Motion is quantified by the tensile displacement opposite each loaded rim… |
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: