Recognized standard
7206-10 Second edition 2018-08
FDA recognition 11-389 · ISO · Orthopedic
Key facts
| Recognition number | 11-389 |
|---|---|
| Designation | 7206-10 Second edition 2018-08 |
| Title | Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads [Including AMENDMENT 1 (2021)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | This document specifies methods of determining the compressive (fracture) or the tension (disassembly) loads required, under specific laboratory conditions, to cause failure of a modular head system. This document applies to components made of metallic and non-metallic materials, such as femoral… |
At a glance
- 10–99 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: