Recognized standard
F2423-11 (Reapproved 2020)
FDA recognition 11-269 · ASTM · Orthopedic
Key facts
| Recognition number | 11-269 |
|---|---|
| Designation | F2423-11 (Reapproved 2020) |
| Title | Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Aug 21, 2017 |
| Device classes | Class 3 |
| Scope (excerpt) | 1.1 This guide provides guidance for wear and/or fatigue testing of total disc prostheses under functional and kinematic conditions and, to this end, describes test methods for assessment of the wear or functional characteristics, or both, of total disc prostheses. 1.2 Both lumbar and cervical… |
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: