Recognized standard
F1582-98 (Reapproved 2016)
FDA recognition 11-175 · ASTM · Orthopedic
Key facts
| Recognition number | 11-175 |
|---|---|
| Designation | F1582-98 (Reapproved 2016) |
| Title | Standard Terminology Relating to Spinal Implants |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Aug 21, 2017 |
| Scope (excerpt) | 1.1 This terminology covers basic terms and considerations for spinal implant devices and their mechanical analyses. |
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: