Recognized standard
F382-17
FDA recognition 11-333 · ASTM · Orthopedic
Key facts
| Recognition number | 11-333 |
|---|---|
| Designation | F382-17 |
| Title | Standard Specification and Test Method for Metallic Bone Plates |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | 1.1 This specification and test method is intended to provide a comprehensive reference for metallic bone plates used in the surgical internal fixation of the skeletal system. The standard establishes consistent methods to classify and define the geometric and performance characteristics of bone… |
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: