Recognized standard
F3292-19
FDA recognition 11-369 · ASTM · Orthopedic
Key facts
| Recognition number | 11-369 |
|---|---|
| Designation | F3292-19 |
| Title | Standard Practice for Inspection of Spinal Implants Undergoing Testing |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Jul 6, 2020 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | 1.1 This practice provides guidance for non-destructive photographic analysis of spinal implants prior to, during, and after testing. The purpose of this practice is to provide methods for documenting notable changes in implant characteristics (e.g., surface defects, cracks, plastic deformation)… |
At a glance
- 10–99 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: