Recognized standard
F543-17
FDA recognition 11-327 · ASTM · Orthopedic
Key facts
| Recognition number | 11-327 |
|---|---|
| Designation | F543-17 |
| Title | Standard Specification and Test Methods for Metallic Medical Bone Screws |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws… |
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: