Recognized standard
F983-86 (Reapproved 2018)
FDA recognition 11-197 · ASTM · Orthopedic
Key facts
| Recognition number | 11-197 |
|---|---|
| Designation | F983-86 (Reapproved 2018) |
| Title | Standard Practice for Permanent Marking of Orthopaedic Implant Components |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 1, Class 2, Class 3 |
| Scope (excerpt) | 1.1 It is common practice for orthopaedic implant manufacturers to apply permanent identification to implant components. In this regard, Practice F86 describes recommended locations and methods of marking for metallic implants. 1.2 The purpose of this practice is to (1) recommend that orthopaedic… |
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: