Recognized standard
7207-1 Third edition 2007-02-01
FDA recognition 11-232 · ISO · Orthopedic
Key facts
| Recognition number | 11-232 |
|---|---|
| Designation | 7207-1 Third edition 2007-02-01 |
| Title | Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | This part of ISO 7207 classifies femoral, tibial and patellar components for knee joint prostheses in which the bearing surfaces of one or more compartments of the knee are replaced. It also gives definitions of components and the designation of dimensions. |
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: