Recognized standard
F2193-20
FDA recognition 11-375 · ASTM · Orthopedic
Key facts
| Recognition number | 11-375 |
|---|---|
| Designation | F2193-20 |
| Title | Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 21, 2020 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 These specifications and test methods are intended to provide a comprehensive reference for the components of systems used in the surgical fixation of the spinal skeletal system. The document catalogs standard specifications that specify material, labeling, and handling requirements. The… |
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: