Recognized standard
F1378-18e1
FDA recognition 11-360 · ASTM · Orthopedic
Key facts
| Recognition number | 11-360 |
|---|---|
| Designation | F1378-18e1 |
| Title | Standard Specification for Shoulder Prostheses |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 23, 2019 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | 1.1 This specification covers shoulder prostheses for total or hemiarthroplasty used to provide functioning articulation by employing glenoid and humeral components. 1.2 Devices for custom applications are not covered by this specification. Modular prostheses are included in this specification. |
At a glance
- 1–9 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: