| ISO 5838-3 First edition 1993-09-15 Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 11-75 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Orthopedic |
| FDA Tech | Jonathan Peck FDA/OMPT/CDRH/ODE/DOD/PSDB/ 301-796-5650 jonathan.peck@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| Regulation Number | Device Name | Device Class | Product Code |
| §888.3040 | Pin, Fixation, Smooth | Class 2 | HTY |
| §888.3040 | Pin, Fixation, Threaded | Class 2 | JDW |
| §888.3030 | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class 2 | KTT |
| Reviewers Guidance Checklist for Orthopedic External Fixation Devices, 2/21/97 |