Recognized standard
F2267-04 (Reapproved 2018)
FDA recognition 11-185 · ASTM · Orthopedic
Key facts
| Recognition number | 11-185 |
|---|---|
| Designation | F2267-04 (Reapproved 2018) |
| Title | Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | 1.1 This test method specifies the materials and methods for the axial compressive subsidence testing of non-biologic intervertebral body fusion devices, spinal implants designed to promote arthrodesis at a given spinal motion segment. 1.2 This test method is intended to provide a basis for the… |
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: