Recognized standard
F1798-21
FDA recognition 11-402 · ASTM · Orthopedic
Key facts
| Recognition number | 11-402 |
|---|---|
| Designation | F1798-21 |
| Title | Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 18, 2023 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This test method covers the measurement of uniaxial static and fatigue strength, and resistance to loosening of the component interconnection mechanisms of spinal arthrodesis implants. 1.2 The purpose of this test method is to provide a means of mechanically characterizing different designs of… |
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: