Recognized standard
5838-3 First edition 1993-09-15
FDA recognition 11-75 · ISO · Orthopedic
Key facts
| Recognition number | 11-75 |
|---|---|
| Designation | 5838-3 First edition 1993-09-15 |
| Title | Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of ISO 5838 specifies the characteristics of skeletal wires of the Kirschner type. Material and mechanical requirements are covered by ISO 5838-1. |
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: