Recognized standard
F564-17
FDA recognition 11-325 · ASTM · Orthopedic
Key facts
| Recognition number | 11-325 |
|---|---|
| Designation | F564-17 |
| Title | Standard Specification and Test Methods for Metallic Bone Staples |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This specification covers characterization of the design and mechanical function of metallic staples used in the internal fixation of the musculoskeletal system. It is not the intention of this specification to describe or specify specific designs for metallic bone staples. 1.2 This… |
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: