Recognized standard
5838-1 Third edition 2013-03-01
FDA recognition 11-252 · ISO · Orthopedic
Key facts
| Recognition number | 11-252 |
|---|---|
| Designation | 5838-1 Third edition 2013-03-01 |
| Title | Implants for surgery -- Metallic skeletal pins and wires -- Part 1: General requirements |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Aug 6, 2013 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of ISO 5838 specifies general requirements for metallic skeletal pins and wires for use in bone surgery, excluding wires for binding and twisting. |
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: