Recognized standard
15142-3 First edition 2003-08-01
FDA recognition 11-357 · ISO · Orthopedic
Key facts
| Recognition number | 11-357 |
|---|---|
| Designation | 15142-3 First edition 2003-08-01 |
| Title | Implants for surgery - Metal intramedullary nailing systems - Part 3: Connection devices and reamer diameter instruments |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Jul 15, 2019 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This part of ISO 15142 specifies metallic medical devices used for the temporary intramedullary stabilization of long bones by surgical implantation, classifying and giving other requirements and dimensions for the devices used to insert, remove or both insert and remove intramedullary nails. It… |
At a glance
- None 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: