Recognized standard
F366-17
FDA recognition 11-324 · ASTM · Orthopedic
Key facts
| Recognition number | 11-324 |
|---|---|
| Designation | F366-17 |
| Title | Standard Specification for Fixation Pins and Wires |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This specification covers functional dimensions forfixation pins and wires. 1.2 In recognition of many broad and varied uses of suchpins and wires, many options are included. A variety, but notnecessarily all, of the options are illustrated in Figs. 1-3. |
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: