Recognized standard
F2789-10 (Reapproved 2020)
FDA recognition 11-247 · ASTM · Orthopedic
Key facts
| Recognition number | 11-247 |
|---|---|
| Designation | F2789-10 (Reapproved 2020) |
| Title | Standard Guide for Mechanical and Functional Characterization of Nucleus Devices |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Apr 4, 2016 |
| Scope (excerpt) | 1.1 This guide describes various forms of nucleus replacement and nucleus augmentation devices. It further outlines the types of testing that are recommended in evaluating the performance of these devices. 1.2 Biocompatibility of the materials used in a nucleus replacement device is not addressed in… |
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: