Recognized standard
F1611-00 (Reapproved 2018)
FDA recognition 11-310 · ASTM · Orthopedic
Key facts
| Recognition number | 11-310 |
|---|---|
| Designation | F1611-00 (Reapproved 2018) |
| Title | Standard Specification for Intramedullary Reamers |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | 1.1 This specification provides requirements for material, dimensions and tolerances, finish and marking, and care and handling for reamers intended to cut a cylindrical path along the medullary canal of diaphyseal bone. 1.2 Intramedullary reamers are commonly used to prepare the medullary canal 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: