Recognized standard
F2820-24
FDA recognition 8-643 · ASTM · Materials
Key facts
| Recognition number | 8-643 |
|---|---|
| Designation | F2820-24 |
| Title | Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This specification covers virgin polyetherketoneketone (PEKK) polymer in virgin forms (for example, pellets, granules, powder, filaments used in additive manufacturing) and fabricated forms. It provides requirements and associated test methods for these thermoplastics when they are to be used in… |
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: