Recognized standard
F1717-21
FDA recognition 11-388 · ASTM · Orthopedic
Key facts
| Recognition number | 11-388 |
|---|---|
| Designation | F1717-21 |
| Title | Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of spinal implant components can be specific, depending on the intended spinal location and intended method of… |
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: