Recognized standard
F2502-17
FDA recognition 11-378 · ASTM · Orthopedic
Key facts
| Recognition number | 11-378 |
|---|---|
| Designation | F2502-17 |
| Title | Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This specification and test methods cover the mechanical characterization of plates and screws for orthopedic internal fixation. Covered devices are fabricated from one or more hydrolytically degradable polymer (from this point on referred to as "absorbable") resins or resin composites. 1.2 This… |
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: