Recognized standard
F1829-17
FDA recognition 11-334 · ASTM · Orthopedic
Key facts
| Recognition number | 11-334 |
|---|---|
| Designation | F1829-17 |
| Title | Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | 1.1 This test method covers a method for determining the static shear disassembly force of modular anatomic glenoid components used in anatomic total shoulder arthroplasty prostheses. 1.2 Although the methodology described does not replicate all physiological force conditions, it is a means of in… |
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: