Recognized standard
F983-24
FDA recognition 11-424 · ASTM · Orthopedic
Key facts
| Recognition number | 11-424 |
|---|---|
| Designation | F983-24 |
| Title | Standard Practice for Permanent Marking of Orthopaedic Implant Components |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 1, Class 2, Class 3 |
| Scope (excerpt) | 1.1 The purpose of this practice is to (1) recommend that orthopaedic implants be permanently marked, and (2) recommend practical amounts of information that should be included in the marking. It is recognized, however, that marking is not practical in some cases (see 5.1). |
At a glance
- 100–999 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: