Recognized standard
F2346-18
FDA recognition 11-343 · ASTM · Orthopedic
Key facts
| Recognition number | 11-343 |
|---|---|
| Designation | F2346-18 |
| Title | Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Jan 14, 2019 |
| Device classes | MJO |
| Scope (excerpt) | 1.1 These test methods specify the materials and methods for the static and dynamic testing of artificial intervertebral discs. 1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future non-biologic artificial intervertebral discs. These… |
At a glance
- None 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: