Recognized standard
F1357-14 (Reapproved 2019)
FDA recognition 11-294 · ASTM · Orthopedic
Key facts
| Recognition number | 11-294 |
|---|---|
| Designation | F1357-14 (Reapproved 2019) |
| Title | Standard Specification for Articulating Total Wrist Implants |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Aug 14, 2015 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | 1.1 This specification describes total wrist implants, including solid ceramic implants, used to provide functioning articulation by employing radial and carpal components. 1.2 This specification excludes those implants with ceramic-coated or porous-coated surfaces, one-piece elastomeric implants… |
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: