Recognized standard
F1781-21
FDA recognition 11-387 · ASTM · Orthopedic
Key facts
| Recognition number | 11-387 |
|---|---|
| Designation | F1781-21 |
| Title | Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This specification covers elastomeric flexible hinge finger total joint implants, used with and without metal grommets, in the reconstruction of the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints. 1.2 This specification excludes those implants that do not have an… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
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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: