Recognized standard
15142-2 First edition 2003-08-01
FDA recognition 11-356 · ISO · Orthopedic
Key facts
| Recognition number | 11-356 |
|---|---|
| Designation | 15142-2 First edition 2003-08-01 |
| Title | Implants for surgery - Metal intramedullary nailing systems - Part 2: Locking components |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Jul 15, 2019 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | Intramedullary nailing is a method of fixation for temporary stabilization of long bones with reduced strength due to fractures or disease or both. Medical and engineering considerations influence the design of the different devices and the choice of a device for a particular clinical situation… |
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: