Recognized standard
F2943-14 (Reapproved 2019)
FDA recognition 11-283 · ASTM · Orthopedic
Key facts
| Recognition number | 11-283 |
|---|---|
| Designation | F2943-14 (Reapproved 2019) |
| Title | Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Jan 27, 2015 |
| Scope (excerpt) | 1.1 The goal of this guide is to recommend a universal label format (across manufacturers and various implants) of content and relative location of information necessary for final implant selection within an implant's overall package labeling. 1.2 This guide recommends package labeling for… |
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: