Recognized standard
5838-2 First edition 1991-01-15
FDA recognition 11-74 · ISO · Orthopedic
Key facts
| Recognition number | 11-74 |
|---|---|
| Designation | 5838-2 First edition 1991-01-15 |
| Title | Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -- Dimensions |
| 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 dimensions of Steinmann skeletal pins. Material and mechanical requirements are covered by ISO 5838-1. NOTE 1 Attention is drawn to the possible need for different designs of points depending on such factors as the method of insertion, and the site of insertion… |
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: