Recognized standard
F2180-17
FDA recognition 11-329 · ASTM · Orthopedic
Key facts
| Recognition number | 11-329 |
|---|---|
| Designation | F2180-17 |
| Title | Standard Specification for Metallic Implantable Strands and Cables |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This specification covers the materials, dimensional tolerances, constructions, and mechanical properties for standard metallic implantable strands and cables. 1.2 This specification is intended to assist in the development of specific strand and cable specifications. It is particularly… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
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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: